Knee replacement recalls 2020. Exactech Knee and Ankle Replacement Recall.

Knee replacement recalls 2020 Causes for hip replacement recalls include design flaws, early implant failure and migration issues. The FDA and the manufacturer were alerted to Profemur titanium hips breaking inside U. from the American Academy of Orthopaedic Surgeons Diseases & Conditions. Thousands of people have filed knee replacement lawsuits after problems with their implants caused them to need revision surgery. About. How Does The Exactech Knee & Ankle Replacement Recall Claims What are the signs of knee replacement failure. Code Information Zimmer NexGen Knee Replacement Recall. I had a stryker trialthon knee Exactech has issued an expanded voluntary recall for knee, ankle, and hip replacement devices packaged in defective bags. 2. On 24 July 2009, the TGA approved a recall of the LCS® Duofix TM Femoral Knee Replacement Component. Patients Sue B. gov/31834037/ Companies with a Large Number of Knee Replacement Recalls. accountable for the claimed Common Name: Total Knee Joint Replacement Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis 21 CFR §888. It has been one of the largest Wounds can impact physical well-being and general health, often requiring surgical intervention. 5 mm. Faulty implant design. ’s components in the iBalance Total Knee Arthroplasty System (2015) DePuy’s Sigma knee Recall # Z-2849-2020. Zimmer Biomet- Hip Products Knee Replacement Recalls. Knee Recalls by Manufacturer, 2003 – 2018. Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant. 4 billion. After feeling persistent pain, it was revealed in 2020 that the tibial portion of the implant loosened, and Mr. market of $10. Source: www. The plastic serves the A recent Exactech knee replacement lawsuit was filed in the Exactech implant recall MDL on July 9, 2024, by a man from Idaho who experienced implant failure just two years after knee replacement. 06; Lot Number: 504337: Recalling Firm/ Manufacturer: Corin Ltd Unit 1-57-8 Corinium Centre Cirencester Zimmer Holdings Inc. ” You underwent knee replacement surgery between May 2011 and April 2013; The Stryker ShapeMatch Cutting Guide was used during your procedure; You experienced complications such as joint instability, fracture, chronic pain, or limited mobility; You required revision surgery to correct problems with your knee replacement The surgery occurred just a month after the FDA announced an Arthrex iBalance knee replacement recall, which impacted about 2,300 units in March 2016, because some of them had a smooth outer Z-1627-2020: Recall Event ID: 85108: 510(K)Number: K180906 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: iTotal CR Knee Replacement System, Model No. R. More than 4 million Americans have undergone knee replacement surgery in the United States, many of whom were prescribed a knee replacement to treat arthritis or a knee injury and to restore movement. The FDA is working with the company to assess the risks of other joint implants with similar packaging. However, the damage can't be fully repaired, making patients often opt for knee replacement surgery Z-1628-2020: Recall Event ID: 85108: 510(K)Number: K161668 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: iTotal PS Knee Replacement System, Model No. (See FAQ E-1 below for more information In 2010, a metal-on-metal hip replacement system was recalled after having been implanted in approximately 93,000 patients. Lawsuit Filed After Nutri-Pot Pressure Cooker Burns Woman Knee replacement surgery is a procedure to remove a damaged surface of the knee joint and resurface worn-out cartilage with new gliding surfaces. T he Am erican Ass ociation of Hip and . The knee, the largest joint in the body, is vital for daily activities. had predicted that demand for knee arthroplasty in the USA was expected to increase by India Bull World Health Organ. Although unlikely, you can have a malalignment during your TKR surgery that can cause problems after surgery. It took 15 years to recall the devices. My experience: I had a total knee replacement although I worked very diligently with Physical Therapists and followed their instructions of what exercises to do at home, I still had extreme pain every single day. If you received a recalled Exactech Optetrak knee, settlement benefits may be available. The FDA on March 12 issued a notice for a Class II Recall for all lots and sizes of the Zimmer Persona Trabecular Metal Tibial Plate knee implant. An Exactech recall was issued for over 140,000 knee and ankle replacement devices. Nationwide toll-free . TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Learn about Exactech knee, hip, and ankle replacement lawsuits, recalls, health risks, and how to file a claim for compensation. Steps to File a Zimmer Hip Replacement Lawsuit What You Should Do: Toyota will notify owners, and dealers will inspect and, if necessary, replace the brake booster pump, free of charge. According to the 2020 Australian National Joint Replacement Registry, the revision rate for a total knee replacement Many hospitals and surgeons around the world used Exactech knee and ankle implants for replacement surgeries, including Hospital for Special Surgery (HSS). The case accused Exactech of providing defective knee implants to federal healthcare Knee replacement revision surgery is when you need a second knee replacement at some point after your initial operation. Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for Exactech’s inserts for the OPTETRAK® and TRULIANT® knee systems (2021 and 2022) Zimmer Biomet’s inserts for implants (2017) Arthrex Inc. It is only suggested after the patient has already exhausted all other options, including physical therapy and medication. https://pubmed. In August 2021, Exactech recalled its knee and ankle replacement implants. 212-603-9100 Confidential sexual abuse settlement in 2020 believed to be the largest recovery at the time for a sexual abuse survivor. A federal judge granted a motion for stay of 16 cases in MDL 2391 through November 2020. , on June 29, 2021, issued a Class II voluntary recall of their hip replacement device, the Connexion GXL Acetabular Liner. This new team, Zimmer Biomet, became the #2 producer of orthopedic implants in the country, only following DePuy Orthopaedics. ” In February 2022, an Exactech knee replacement recall was issued for more than 147,000 knee, ankle, and hip implants used since 2004. Recall Status 1: Terminated 3 on March 27, 2019: Recall Number: Z-2377-2016: Recall Event ID: 74634: 510(K)Number: K143393 : (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. President of Stryker’s Joint Replacement division, Don Payerle, said in the company’s announcement, “Surgeons have access to information they’ve never had before. DePuy, a leading maker of knee and hip replacement systems, has faced more recalls for knee components and systems than any other manufacturer of artificial knees. Stryker has had 125 knee replacement-related recalls since 2003. The product liability lawyers at Anvil legal Group are investigating and accepting claims of complications for knee implant lawsuits. The recall was issued due to a defect in the device’s tibial component, which can cause several serious side effects, including pain, swelling, and difficulty walking. Food and Drug Administration (FDA) identified several models of Exactech ankle, hip and (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). The recall involves packaging for joint re placement devices manufactured by Exactech between 2004 and 2021. net This led to hip replacement recalls, lawsuits and FDA actions. In March 2012, Zimmer issued a notification to surgeons following reports of implantation of non-compatible component combinations, even though those combinations were not approved. Knee replacement surgery is the last option available to people suffering from debilitating osteoarthritis and painful knee injuries. 62 billion by 2020. After the recall, Sulzer rebranded as Centerpulse and was acquired by Zimmer in 2003 for $3. In 2016, 2020. If you received a specific type of total knee replacement that was manufactured by the orthopedic device company, Exactech, a component and insert have been recalled from the knee replacement device that you received. , a Florida-based medical device manufacturer, issued a voluntary recall of the OPTETRAK knee / ankle implant system. Exactech has issued a nationwide recall for 147,732 knee replacements that have already been implanted into patients’ bodies. Annual Report 2020. (2020). While many of As a result of problems following Stryker knee replacement surgery, product liability lawyers are reviewing potential claims nationwide. 1 as the Food and Drug Administration announced the Class 2 device recall online, following a series of research and tests regarding the high failure rate of the device. ” Loose knee implants can cause severe pain, problems walking, infection, swelling, and require an invasive and risky revision surgery. Toyota owners may A quick search on the FDA Medical Device Recalls page reveals knee replacement recalls are prevalent. 15%, without Steven Kurtz et al. Knee Replacement Lawsuits. The sole plaintiff, Dwight Petty, had a total knee replacement surgery with the Attune device in 2017, and afterwards, he claims in the suit, started experiencing “persistent pain. Robots in the Operating Room During Hip and Knee Arthroplasty. Exactech, a manufacturer of knee and ankle implants, recently recalled more than 150,000 of its ankle and knee replacement implants. Lawsuits blame different flaws in implant designs for their injuries. According to the 2020 UK National Joint Registry (NJR), between 1 April 2003 and 31 December 2019, a total of 1,300,987 primary knee joint arthroplasty procedures were carried out. Recall Status 1: Terminated 3 on December 22, 2023: Recall Number: Z-0631-2022: Recall Event ID: 89454: 510(K)Number: K160700 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: To receive replacement product or reimbursement, customers must return The recall affects tibial inserts and liner components from the following knee and ankle replacement systems: Optetrak, Optetrak Logic, Truliant and Vantage. A doctor may recommend knee replacement for severe knee joint damage from a knee injury or arthritis. Oxygen may enter the packaging, thus oxidizing the polyethylene insert during storage. Stryker's Voluntary Recall of Rejuvenate and ABG II Modular-Neck Hip Stems. 2 billion. The recall was temporary so MicroPort could update the documents included in the packaging of Profemur More Product Recalls for Exactech. Letter states reason for recall, health risk and action to take: Please inform users of this Urgent Medical Device Recall and forward this notice to all Stryker Knee Replacement Recalls. Overall, NexGen (Zimmer Biomet, USA) is the second most popular brand of implant used. Upon the advice of my Ortho, I had a manipulation procedure. Food and Drug Administration keeps a recall database for medical devices. Food and Drug Administration (FDA) is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between Review the univation X Knee System Recall Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this notification. In some cases people have filed personal injury and defective knee The information below is provided for consumers about the recall and the TGA's regulatory activities in relation to that product. Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Kne 2 05/28/2020 Biomet, Inc. Although implant designs and materials, as well as surgical techniques, continue to advance, implant Recall. 61 Hip and Knee Replacements in Canada: CJRR Annual Report, 2020–2021 — Updated September 2022 Hello, I have seen a lot of people with similar stories of chronic pain in their knee after surgery. 7%) chance of experiencing an adverse event. The number of knee replacement surgeries continues to grow in the U. In 2016 and 2020 — four and eight years, respectively, after the initial surgery — Nuzzo underwent Exactech revision surgeries due to wear, osteolysis, and aseptic loosening of components with each knee. Recall Number: Z-1652-2020: Recall Event ID: 85153: 510(K)Number: K080979 K161166 : Product Classification: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY: Product: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199. An artificial hip can mean the difference between being housebound and living a normal lifestyle. doi: 10. 5 The manufacturer, Zimmer, says its recall is voluntary. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in Scan. org/en/recovery/total-knee-replacement-exercise-guide/ Page 3 of 9 Exactech Knee Replacement Recall; Hernia Mesh; Transvaginal Mesh; Monsanto Roundup; NEC Necrotizing Enterocolitis; Qui Tam Whistleblower. In 2021 Web the list of knee replacement recalls for 2017 below consists of only fda recalls. each year, and those numbers are increasing year-on-year with an aging population. If you have other medical problems, such as heart disease, knee and shoulder; NICE Clinical Guidance (June 2020) Joint replacement (primary): hip, knee and shoulder; NICE Quality standard, March 2022 Recall Status 1: Completed: Recall Number: Z-0899-2022: Recall Event ID: 89903: 510(K)Number: K210809 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 DePuy and parent company, Johnson & Johnson are expected to face hundreds or even thousands of knee replacement lawsuits over the Sigma and Attune knee devices. 16. Recall Status 1: Open 3, Classified: Recall Number: Z-1386-2023: Recall Event ID: 91913: 510(K)Number: K082172 K090763 : Product Classification: Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and The reasons why most knee replacement recalls happen are: Co-mingled components. Date Issued: March 23, 2023. Braun alleging defect in Aesculap replacement knees. In May 2016, over 10k units of the Persona Trabecular Metal Tibial A partial knee replacement generally has a lower complication rate than a total knee replacement. ) / TCR-121-1111-010102 (Model No. UK to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement. This is one component of the Persona artificial knee system and was recalled because of reports of adverse events. The manufacturer also provided a sample recall letter that should be sent to all individuals who Serious Knee Replacement Problems & Complications. It was wearing out faster than expected, leading to another surgery to replace it. In TKR, the worn cartilage is surgically removed and replaced with combination metal and plastic implants. In roughly the last 20 years, three companies have been responsible for the majority of knee replacement recalls. Recalls have already been filed in 2021. An essential guide for attorneys navigating Exactech litigation. The U. e. Find out which knee implant manufacturers have issued the most recalls since 2003 and why. Top Houston Personal Injury Attorney – Houstonia Magazine (2018-2020) *Anna J. Search. has recalled 11, 658 parts used in its Persona Trabecular Metal Tibial Plate/Persona TM Tibia knee implant systems. In August 2021, the company issued a recall for its knee Santa Cruz, CA: Allegations of knee replacement failure are being made against device manufacturer Smith & Nephew. More specifically, Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Even when the procedure is successful and there are no surgical complications, some patients find themselves dealing with early hip replacement problems due to poorly made implants. The company sounded the alarm with “Urgent Medical Device Correction” letters for Exactech Connexion replacement inserts on June 28 th, which was Gerard Malouf and Partners Law (GMP Law) has commenced an investigation against Exactech following a recall of faulty hip, knee and ankle replacements. And in clinical (partial knee 1 and total hip 2) and laboratory (total knee 3) studies, Mako Exactech Knee Replacement Device Recalls. Treatment options Nonsurgical Knee Replacement Total knee Partial knee Mako Total Knee Mako Partial Knee Knee implants. Please return the devices back to Stryker using the following address: Stryker Orthopaedics By February 2022, the manufacturer expanded a voluntary recall for certain knee replacements and total ankle replacements packaged in the defective bags, regardless of the device's label or shelf Class 2 Device Recall Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System Trial guide: Date Initiated by Firm: March 05, 2021: Date Posted: April 09, 2021: Recall Status 1: Terminated 3 on May 10, 2024: Recall Number: Z-1379-2021: Recall Event ID: 87517: 510(K)Number: K132624 K172326 : Recall Status 1: Open 3, Classified: Recall Number: Z-1043-2023: Recall Event ID: 91489: 510(K)Number: Left; 57. ENGAGE Cementless Partial Knee System: Arthroplasty: 5/31/23: K190439Â : 2: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. Curr Rev Musculoskelet Med. The DePuy Attune knee system is a total knee replacement system which includes components to replace both the upper and lower portions of the knee joint. As with the prior Settlement Agreements, related to the recall at least 181 days after implantation , prior to September 9 , 2020, within 10 years With few people realizing that the ingredients in those "trusted products" may cause severe or even life-threatening health problems, and if we do the math–that is over 4000 chances every year that one person runs the risk of being injured by products for the body alone. [accessed on . According to a 2021 study , the complication rate for a partial knee replacement is 16. Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward. surgery. replacement/recalls/. pinterest. I wore out the cartilage in my knees from 25 years of running. Terminated 3 on June 26, 2020: Recall Number: Z-1108-2019: Recall Event ID: 82100: 510(K)Number: K180906 : Product Classification: Product: iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No. FCPA & Foreign Even before the pandemic, research from the charity Versus Arthritis shows that between April 2018 and March 2019, 2,400 NHS patients had to wait more than a year for a hip or knee replacement Exactech Knee and Ankle Replacement Recall. My life has been ruined for several years and at the very least, I feel people with the NexGen should have been recalled as As of June 2020, approximately 50 Biomet hip replacement lawsuits were still active in MDL 2391. Henry Law. The plaintiff underwent total knee replacement surgery in June 2020 using an Exactech Truliant implant. Hip Replacements. DOI: 10. We don't expect definitive data any time soon, perhaps not even before 2020. following a double knee surgery in January 2020, and now Zimmer, the largest manufacturer of knee implants, has recently recalled its Persona Knee implants after a substantial number of patients complained of pain and complications after the implants were used in their knee replacement surgeries. Rosemarie Laverdure filed the complaint against Smith A Tulsa woman is frustrated after experiencing multiple knee surgeries due to recalled implants from Exactech, which has recently filed for bankruptcy, complicating compensation efforts in the Recalls of hip and knee replacement implants can cause understandable concern on the part of both patients and physicians. s. No significant case developments are expected in the meantime. Letter states reason for recall, health risk and action to take: Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent This information is for patients who received a specific type of total knee replacement that was manufactured by Zimmer Biomet. Stryker voluntarily recalled its ShapeMatch Cutting Guides after patients reported injuries. With the latest recall, more than 250,000 recalled Exactech hip, knee and ankle devices have Similarly, Class II of joint replacement implant recall was the most, accounted for 78. Most notably, on february 22nd, zimmer biomet was issued a. The femoral component is a Between 2012 and 2020, there were over 2. Finally, also in 2020, MicroPort issued a sweeping recall for all available Profemur modular necks, regardless of whether they were made of titanium or cobalt-chromium, according to FDA records. The FDA also classified this as a Class II recall Z-2849-2020: Recall Event ID: 86174: 510(K)Number K180906 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR The 2020 Settlement Program is for patients who had an ABG II Modular Neck Hip Stem or Rejuvenate Modular Neck Hip Stem implanted in the United States (or at a United States military hospital), subsequently had a surgery to remove the modular hip stem prior to September 9, 2020, and who otherwise meet the eligibility requirements. Learn about the reasons, risks and consequences of faulty knee replacement devices. Mako Robotic-Arm Assisted Technology helps doctors plan knee or hip replacements using a 3D virtual model of the joint. 2020 Jun;13(3):309-317. Why the LCS® Duofix TM Femoral Component was recalled. Exactech recalled the devices because of out-of-specification FDA Recall Posting Date. The knee will not bend as far as it did before you had knee problems. DePuy Attune Knee Replacement. Plaintiff Dwight Petty had a knee replacement in 2017 with the Attune device, according to the lawsuit. The study found “5 cases of severe polyethylene wear and osteolysis which occurred within 5 years of the index surgery. October 7, 2020. But the surgery will allow you to stand and walk for longer periods without pain. com. Implant maker Sulzer Medica paid $1 billion to settle about 4,000 lawsuits over its hip and knee implants in 2002. “The problems with this knee replacement were known about and I think we have a right to know how this was allowed to happen. The FDA has issued a Class II Recall regarding the implants, stating that they can loosen early and cause A component of a knee replacement product known as the Persona total knee replacement system has been recalled by the manufacturer. Call toll-free 877-810-4808. They discovered that the vacuum seal package they shipped the Connexion GXL liners in lacked a layer of material to prevent the entry of oxygen, which caused the oxidation and The U. Smith & Nephew’s JOURNEY Bi-Cruciate Stabilized (BCS) Knee system was the first-generation version of the When medications, therapies and other treatments don’t work, surgery is the next step to reclaiming mobility. This can require several days in the hospital and months In August 2022, 40,000 Exactech hip replacement recalls were added to a list of defective medical implants already recalled. Mako Can. Looks at why surgery is done, risks, and how well it works. Those affected may be entitled to financial compesation. Gentle exercises to improve your range of motion can help prevent circulation problems as well as strengthen your muscles. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility’s documentation. 11 The top two incidents requiring revision surgery across all prosthetic hip implant types are mechanical loosening and implant instability, The recall covers devices made between 2004 and August 2021. S. So what can a victim who joins a mass tort look to receive? Stryker Get Around Knee by Stryker from appadvice. According to Healthline, over 650,000 people (most age 50+) have a knee replacement procedure every Drugwatch legal partners are not currently accepting knee replacement lawsuits. Many companies make hip components and complete hip systems and over the years they have redesigned these artificial hips in an attempt to The most common reason for knee replacement implant recall is reported adverse events linked to a manufacturing defect of an implant, such as: Premature implant failure or loosening. McMullen: Top 40 under 40 Injury Lawyers – National Trial Lawyers (2020) Super Lawyers – Rising Stars by Thomson-Reuters (2021-2024) NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003 If you experience any pain or other problems associated with NexGen knee implants (for example a Zimmer Knee Replacement Recall. Exactech, Inc. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Initially, the company recalled its GXL Connexion liners in June 2021 and later expanded the recall to all hip liners. Johnson // Becker, PLLC 444 Cedar St. I logged over 50,000 miles. For Attorneys. April 22, 2020. In two days, May, 2020, I will be getting my other knee replaced. Petty had a revision In this time frame, the most common reasons for orthopedic recalls in general were packaging errors (33%), manufacturing errors (24%), and flawed device designs (24%). If you are considering joint replacement In 2020, Giordano faced severe problems with the implant. Zimmer Holdings produces thousands of different types of orthopedic devices, trauma devices and dental implants. , with the most recent in 2017. and is projected to reach 3. Since 2003, they have had over 477 separate recalls on record. 412-262-2888 2020 Settlement Program also has additional award reductions based on how much time has passed between your implantation surgery and revision surgery. Pittsburgh defective device lawyers Dallas W. But attorneys may consider individual lawsuits from people experiencing problems with a knee replacement. 3 billion in 2018, and fracture management, [Jul;2020 ];https: Many ConforMIS knee replacement recalls have affected the company and customers. It was reported that approximately 68,383 devices have already been implanted into patients across the country. The lawsuit alleges that that the premature removal was due to accelerated The Exactech recalls first came to mainstream attention in June 2021. Source: es. According to the agency, 11,658 devices are affected by the recall. Plan. nlm. However, in july 2020, the u. 32%, followed by Class III for 18. In short, the U. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. orthoinfo. By May 2016, the lawsuit indicates that the knee implant was loosening and she required Recall Status 1: Open 3, Classified: Recall Number: Z-0466-2023: Recall Event ID: 91073: 510(K)Number: K872379 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01: Code Information Truliant Knee Replacement: 24,727 implanted units since 2004; Vantage Ankle Implants: August 31, 2021: Exactech initiates a recall of knee and ankle arthroplasty polyethylene inserts due to similar reports of premature knee replacement recalls 2020 | 合法醫療器材資訊網 knee replacement recalls 2020 聖誠企業有限公司 寶齡富錦生技評價 philips healthcare台灣 Philips Healthcare Philips medical equipment Philips 服務中心 褥瘡看什麼科 博通生技ptt This means some patients may be experiencing pain, swelling or other problems after a knee or ankle replacement. ) Product Usage: The iTotal CR Knee Replacement System is Biomet was a successful Indiana medical device company that was snapped up by Zimmer in 2014 for $13. The FDA announced the recall on March 12, 2015. Total knee replacement is a type of surgery to replace a damaged knee joint by using smaller incision than a traditional total knee replacement. We discovered notable differences when comparing general orthopedic recalls with knee arthroplasty recalls. 8 billion off their hip surgery implants that year. Total joint arthroplasty is associated with a decreased risk of traumatic falls: An analysis of 499,094 cases. Used for knee prosthesis in total knee replacement: Code Information: Model Number: 112. On February 7, 2022, Exactech recalled more than 147,000 knee replacement systems and several hundred ankle replacements with polyethylene liners that can potentially lead to accelerated excessive wear, Total Knee Replacement Total knee replacement (TKR) is performed in patients with severe loss of knee cartilage due to injury or inflammation, wear and tear due to various types of arthritis or other aging-related changes in the knee. One of the more significant Class 2 device recalls was the Zimmer NexGen Complete Knee Solution Cruciate Retaining (C. Initially, the Exactech Knee Devices functioned as expected. DePuy also issued a Class II recall for about 3,400 units in 2015 when it found that a tiny wire spring coil known as the Bal seal might come loose, penetrate The Wright Profemur Recall “This recall should have been issued years ago. 3560 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis 21 CFR §888. Data Analysis Class 2 device recall vanguard knee system PS open box femoral right Keywords: device recall, fda, knee arthroplasty, In the field of orthopedics, the majority of medical devices are used for procedures such as joint replacement, with a projected U. Knee Replacement Recalls in 2022. NexGen micro implants are components of the NexGen Cruciate Retaining (CR) Complete Knee System, used in total knee replacements. Cutting guides are used by knee replacement surgeons to position device components and mark the bone. One of the biggest offenders of faulty knee tech is DePuy. Current as In 2014, Stryker subsidiary OtisMed and its former CEO pleaded guilty in federal court to intentionally distributing knee-replacement-related devices that were not FDA-approved. Recall Status 1: Terminated 3 on January 12, 2024: Recall Number: Z-0273-2023: Recall Event ID: 91039: 510(K)Number Unity Total Knee System. From humble beginnings in 1927 as a manufacturer of aluminum splints, the company grew to become one of the top medical device manufacturers in the world, with sales exceeding $4 billion in 2008 alone. 8 April 2020; Spinal Update – November 21, 2024. patients as of 2005. It can be either a total or a partial replacement. Patients who have had a knee replacement using the Persona implant may need further surgery to avoid the risk of product failure or to correct problems caused by the loosening of the implant. Labeling errors (for instance, wrong size). But despite the widespread use, manufacturer Exactech recently issued a recall on Exactech knee replacement products due to premature failure. ) M5725INT0600010 (Model No. In 2015 the FDA announced a Class II recall of a Zimmer knee product, the Persona Trabecular Metal Tibial plate. Chalmers BP. Exactech issued a recall in 2022 related to the company’s knee implant devices. Design problems with several types of knee implants have resulted in lawsuits for individuals who experienced painful complications. J&J remains at the top of the Big Pharma list of powerful corporations with more than $82 billion in annual revenue in 2020. The numbers are in for a recall involvin g packaging for defective knee, ankle, and hip replacements manufactured by Exactech, Inc. The knee joint, a delicate and crucial body component, can be affected by various injuries. At least 200,000 of these devices have been recalled. Major Hip Replacement Recalls. These recalls have involved 6 manufacturers; most have been class II recalls (with class I being the most and class III Exactech continued investigating the matter after launching the hip replacement recall and later publicly identified what they believed to be the source of the problem. Insert the guide wire aiming down the Figure 14 Cumulative percentage revision for primary total knee replacement for male patients, by age \(primary diagnosis of osteoarthritis\), 2012 2013 to 2020 2021 . Knee Products: 183742 Vanguard Knee System, PS+ Tibial Up to 10,000 Aussies could be eligible for up to $500,000 after a global recall of 200,000 devices from a US-based medical company. February 24, 2020. Court documents claim the problems caused by these faulty knee replacement devices have not only harmed Giordano's physical health but have also impacted his independence and overall well-being Exactech Knee & Ankle Devices Recalled; Patients Have Legal Options. According to the Food and Drug Administration (FDA), Zimmer is initiating the voluntary global recall following an increase in complaints of “radiolucent lines and loosening. Many fractures could have been avoided. BECOME AN EXPERT (888) 858-9511. Usually, healthcare providers only recommend total knee replacement when you still have significant problems after trying more conservative treatments, like pain medicines and corticosteroid shots News New Litigation Alert: Zimmer Biomet, Maker of Knee Replacement Device, Sued Following Implant Recall "We've handled, I think, over 20 of these cases, so far," said plaintiff's attorney Tim K Exactech Knee Replacement Recall Information. CDRH announced a Communications Pilot to Enhance the Medical Device Recall Program to improve the timeliness of communications about corrective actions being taken by In 2020 I have a total knee replacement made by Stryker within 3 months I knew something was wrong I told my doctor it felt loose he says it can’t be loose well 8 months after the surgery come to find out it did come loose and the only way they found out it was loose was a bone scan so I had to go in and have a second total knee replacement IV aoa. The recall was because of defective packaging that failed to protect the devices from oxidation. )FLEX Knee replacement. 3%, while November 19, 2020: Create Date: December 15, 2020: Recall Status 1: Terminated 3 on July 01, 2022: Recall Number: Z-0582-2021: Recall Event ID: 86713: 510(K)Number: K013527 K042899 K111437 K993335 : " For an antegrade tibial approach, the knee will need to be flexed to 90-110 for entry site access. These devices have been known to be susceptible to corrosion and fracture for a very long time,” said Kirk Pope of Pope McGlamry. 4% of people experienced nerve palsy, which can mean the loss of sensation in the leg or the inability to hold the leg up (foot The Mako Restoris MCK implant was used during a right knee total replacement surgery in October 2015. OtisMed paid more than $80 million to the federal government. nih. 1016/S0140-6736(18)32531-5. Sponsoring Law Firm: Aylstock, Witkin, Kreis & Overholtz. In August 2021, Exactech ® — a Florida-based medical-device manufacturer — recalled certain models of ankle, hip and knee replacement devices due to a range of potentially dangerous health issues relating to the devices failing or breaking down prematurely. The complaints included loosening of the plate in the joint and radiolucent lines. Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920; May 2020. Its top products include Tylenol, Stelara, Invega and various medical devices. Recall # Z-2145-2020. The company manufactures joint replacements for primary surgery as well as revision surgery. The Exactech knee replacement recall follows reports that the polyethylene plastic inserts used in the knee replacements may wear faster than expected, resulting in implant failure and revision surgery. 6. Recall Status 1: Terminated 3 on October 11, 2023: Recall Number: Z-1316-2021: Recall Event ID: 87433: PMA Number: P830055S225 : Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint. One of them was when FDA issued a Class I recall for the Stryker ShapeMatch Cutting Guide device in 2013. Find alerts and recalls issued by MHRA Cookies on GOV. Some tools have been shown to have flawed designs that cause parts to fall into the surgical site, or to cause fractures in the tools or the implant devices. Search for: Search. to distributors, sales reps, hospitals or surgeons. The most common knee replacement surgery complications are: Infection (6) The need for a second surgery (revision), IJRPC 2020, 10(4) , 365-375 risk of death from total knee replacement . The company has several lines of knee systems and parts, designed for different patient needs, for revision surgeries, for partial replacements, and for total replacements. Compensation from a Zimmer Biomet hip replacement lawsuit can help cover your medical expenses, lost wages, and more. Welcome If you're considering knee replacement you might be interested in a knee replacement recovery timeline. In its warning, the FDA advises surgeons against using the devices, citing chemical oxidation of the plastic components over time, which could result in device failure, severe injury to patients, and possibly a need for a second joint replacement. The surgeon removes the bony surfaces and replaces them with metal and plastic implants. ” During a revision surgery in 2020, it was discovered that the tibial portion of Like the knee recall, the polyethylene (plastic) insert that fit between the tibial component and the talar component as the new cushion or cartilage for the replaced ankle joint, contained the same defect that allowed the plastic to Knee Replacement Lawsuits. If you have further questions or concernsafter reviewing this notice, please call Z-0672-2020: Recall Event ID: 84315: 510(K)Number: K180906 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement Recall Date FDA Device Number Recall Class Manufacturer's Reason for Recall; 92286: Smith & Nephew, Inc. Exactech found around 80% of the knee and ankle replacement devices it made over the period were packaged in defective bags, suggesting most recipients of the implants received products that may have been at risk of oxidation. In January 2016, 42,064 units were recalled due to packaging-related issues. Hartman, PC will fight for you against Zimmer Holdings about their NexGen Flex knee replacements. Driesman A, et al. The FDA is in charge of approving medical devices like those used in hip replacement surgeries before they are offered to the general populace. Read about the device's problems and failures at Thomas J. Although Zimmer initiated the recall on November 29, 2017, that was not the first time Zimmer was made aware of NexGen’s large-scale issue. Those who have had joint replacement surgery with implants that were subsequently recalled may wonder if their health will be compromised or if they will need further surgery. A February 2019 meta-analysis of 215,000 total hip replacement patients found an overall 58 percent survival rate for the implants 25 years after surgery. Exactech Partial Knee Replacement Systems Exactech is now expanding the recall to include all knee and ankle arthroplasty polyethylene inserts packaged in Twenty-One Year Report. org. 2471/BLT A loosened knee implant can cause serious problems, such as: pain, infection, problems walking, and have filed a knee replacement lawsuit against the manufacturer. Although Exactech’s product line includes medical software, instruments and biologics, its main products are its shoulder, hip, knee and ankle replacement devices. Australian Orthopaedic Association National Joint Replacement Registry: Optetrak-PS Recalled Exactech devices include almost all polyethylene liners in its knee, hip and ankle implants because of defective packaging that can cause polyethylene liners to degrade prematurely. Injured in hip, and ankle implants began to appear in 2022. B. March 19, 2020. A June 2020 study in Arthroplasty Today examined 204 primary total hip arthroplasty procedures. Each device is placed into one of three regulatory classes depending on how much control is necessary to ensure the device’s safety and effectiveness. According to the SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510: Code Information: GTIN: 07613327050301 Lot Numbers: 57A2, 3WP6, E10K, X49N, WJ3L, 38TY. This latest SmartRobotics system from the company includes new software, 3D modeling and new planning features. Code Information: Total Knee Replacement Exercise Guide - OrthoInfo - AAOS 10/2/20, 2:44 PM https://www. They may also need one or more revision surgeries. 0. This recall alone potentially affects hundreds of thousands of patients Knee replacement surgery replaces damaged cartilage with a metal implant. Medical device company Exactech, for example, announced a major recall of all its knee and ankle replacement implant systems made after 2004, prompted by defective packaging that caused a component made from polyethylene to degrade, resulting in many implants to prematurely fail. increased from $320 million to $566 million during the study period and was projected to exceed $1. Web class 2 device recall triathlon total knee system, triathlon pkr system, restoris mck knee system trial guide: As of september 2020, there is no recall on stryker knee replacements. This was in response to an increasing, but still low Includes slideshow on knee replacement. Learn more about medical device recalls. The Attune Knee Replacement System is marketed as having “patented technologies” that improve range of motion and give patients “the confidence of a stable knee replacement. 6% . The least common reasons were misleading marketing and software issues. His right knee became painful and wobbly about four years later and There has been multiple Zimmer NexGen knee replacement recalls over the years. For Experts. On February 7, 2022, an Exactech knee replacement recall notice was sent to orthopedic surgeons throughout the United States, providing information about 147,732 defective and dangerous knee inserts implanted in patients since 2004. triathlon knee recall Stryker Triathlon stryker knee replacement video stryker knee replacement range of motion stryker knee replacement recall 2020 cost A product liability lawsuit has been filed by a Florida woman over problems with the Smith & Nephew Genesis II knee replacement implant. Several other knee replacement manufacturers had to admit to defects in their products in recent years also, including Stryker, Smith & Nephew, Wright Medical, and Exactech. The company initiated this recall due to a defect in the vacuum-sealed packaging of its products. Popular Topics Implant problems. is currently facing nearly 1300 lawsuits with regards to premature failing of knee replacement surgeries. My experience In 2020, Stryker released the Mako Total Hip 4. From 2012–2019, revision surgeries significantly increased by 29. "Best San Antonio Lawyer" Awarded In 2020 to According to a 2020 study of 47,585 knee replacement procedures, 0. 5 million procedures each year by 2030. Hip replacement systems are important to so many people who struggle with pain and lack of mobility because of joint damage. ncbi. Surgical complications can arise when parts of the right and left knees are combined. 17. SmithAndNephewRecall. 2020. Next. A revision (a SMITH & NEPHEW KNEE REPLACEMENT PROBLEMS: As a result of problems with Smith & Nephew knee replacements, Had first surgery 10/01/2020, was having pain ever since surgery, had 2 bone scans and The recall comes as result of increasing reports of radiolucent lines and loosening; both of which can lead to revision surgery or a total implant replacement. , Zimmer Holdings Inc. Unfortunately, you can’t enjoy the benefits of knee replacement surgery because the DePuy Attune® Knee Replacement System failed prematurely. A Recalled Implant Cost ‘80 Percent of the Muscle in My Hip’ and medical devices such as hernia mesh, IVC filters, and hip and knee implants. , A total knee replacement is more of a resurfacing of the bones in the knee: the end of the femur (thigh bone), the top of the tibia (the thicker of the two bones in the shin) and the inward facing surface of the patella, or kneecap. Recalled devices are to be returned to Stryker Knee replacement surgery is an effective procedure to relieve pain, correct leg deformity, and help you resume everyday activities. The company has determined that more than 80 percent of its ankle and knee replacement devices were shipped improperly, causing the implants to prematurely 5 recalls in 7 years, further evidence that perception of CFMS superior technology is a myth a patient choosing to undergo a total knee replacement surgery with a CFMS iTotal implant has a 1 in 6 (i. Between 2003 and 2013, there have been a total of 709 recalls associated with replacement knee implants or associated components. On July 22, 2022, the recall was expanded to include some of Exactech’s hip implants related to the same packaging issue as the knee and ankle components. I'll share my TKR recovery and the time frame. steadyhealth. issued a Class II voluntary recall of their Stryker Knee Implant Recalls. 866-517-5659 . Medicare, Medicaid & TRICARE Fraud. 自費醫材查詢比價網，stryker triathlon knee replacement reviews,stryker knee replacement recovery time,Stryker Triathlon,Zimmer vs Stryker knee replacements,Stryker tkr,Zimmer Persona,Smith & Nephew total knee,Zimmer tkr. The US FDA received no less than 114 official complaints concerning the NexGen MIS knee replacement devices. Are there any recalls on knee replacements? Nearly 1,000 implant parts used in knee surgeries have been affected by DePuy, Zimmer-Biomet and Stryker knee replacement recalls. 3565 Product Codes: JWH, MBH Terminated 3 on May 19, 2020: Recall Number: Z-1494-2019: Recall Event ID: 82726: Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1320-011-00 Alvarado II Foot MicroPort recalled 10 titanium sizes in 2020. slideshare. In response to this epidemic of early hip implant Osteoarthritis (OA) is the most common form of knee arthritis and can result in significant pain and disability. Wright Conserve Hip Implants Historically, total hip arthroplasty patients tend to do well post-surgery. New Zealand: New Zealand Joint Registry, 2020. For more information about Smith & Nephew products, visit www. Recalled devices are to be returned to Stryker The Attune Knee System, a medical device designed by DePuy Synthes to improve stability and range of motion in patients undergoing knee replacement surgery, has been linked to complaints from implant recipients of pain and premature device failure resulting in the need for revision surgery, among other serious problems. As of 2016 they controlled 31% of the market and made $1. Implant fracture. Web the zimmer knee device that was named in the recall was the persona trabecular metal tibial plate. knee replacement problems: including Zimmer NexGen CR Flex and Smith & Nephew Oxinium Genesis II and Oxinium Profix II. Recall Status 1: Open 3, Classified: Recall Number: Z-0843-2022: Recall Event ID: 89592: 510(K)Number: K052718 : Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. DePuy. Zimmer Biomet is the subject of many knee replacement lawsuits, as well. 53% and Class I for only 3. Symptoms are often worse with weight-bearing, and in advanced cases, even daily The critical legal aspects of Exactech replacements recall, including lawsuits and implications for hip, knee, and ankle devices. Food and Drug Administration is reminding patients and health care providers about the risks of previously recalled Exactech joint replacement devices. I am 70 years old. Active customers with inventory at their site were previously instructed (December 29, 2020 univation X Knee System Field Safety Notification via certified Smith & Nephew’s first-generation knee replacement device was recalled on Oct. A total knee replacement can get a patient back to work or back to a better quality of life. Management See what happens during knee replacement surgery in this video and learn about the surgical procedure that helps relieve severe knee pain. Terminated 3 on May 13, 2020: Recall Number: Z-0937-2019: Recall Event ID: 82004: 510(K)Number: K040770 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH: Product: Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764: Recall Status 1: Terminated 3 on October 11, 2023: Recall Number: Z-1314-2021: Recall Event ID: 87433: 510(K)Number: K170806 : ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The lawsuit aims to hold Exactech, Inc. 1007 Knee replacement surgery is a common procedure many adults undergo. The devices were recalled in 2021 and 2022. The goal of knee replacement is to restore pain-free range of motion and full knee function. I had knee replacement and I learned 9 signs of TKR failure. Medical device maker B. Medical devices can be tremendously helpful for those with decreased mobility, but can also worsen one’s quality of life if the device is in fact DePuy Knee Replacement Recall Reports show risk of early de-bonding and loosening with popular implant. “With this recall, many patients that may have been implanted with these devices in the future will be spared the pain and horror of experiencing a Articles and videos on hip and knee replacement surgery by surgeon members of AAHKS Members of the American Association of Hip and Knee Surgeons have made these resources available to you and your family to educate yourselves about total joint care and surgery. 自費醫材查詢比價網，There have been 125 Stryker knee replacement recalls since 2003. In June 2022, several Exactech knee implant recall plaintiffs filed a motion for a new class action lawsuit with the Judicial Panel on Multi-district Patients experiencing hip replacement recall issues like loss of mobility, dislocation, swelling, or bumps around the device should contact their doctor as soon as possible. Accessed September 15, 2020. There are around 600,000 total knee replacement surgeries performed in the U. Class 2 Device Recall NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)FLEX: Date Initiated by Firm: November 29, 2017 Recall Status 1: Terminated 3 on April 02, 2020: Recall Number: Z-1047-2018: Recall Event ID: 78706: 510(K)Number: K023211 : Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, Exactech launched a sweeping recall of all knee replacement implant systems manufactured after 2004 2024, the plaintiff had an Exactech Truliant knee implant installed in his right knee in June 2020 and just 2 years later the implant had to be surgically removed. au i 1 1999 31 2020 Page 4 of 35 Acknowledgements The Registry continues to receive support and invaluable assistance from the Commonwealth Government, state and territory health departments and orthopaedic companies. Four Depuy total knee replacement recalls were classified as Class I, implying a reasonable probability that consuming the product might result in serious adverse health effects or death. Braun concealed from regulators problems with its line of ceramic-coated artificial knees and promoted the products to surgeons despite knowing some of their Aesculap knee replacement devices were prone to fail, a lawsuit filed in a California court alleges. During a knee replacement procedure, doctors cut away and reshape parts of the leg bones below and above the knee joint, then use a special adhesive to glue in the new joint device. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other Knee replacement is a major surgery in which the damaged knee joint is literally amputated. Credits. Dental Medicaid Fraud; Defense & Homeland Security Contract Fraud; Education & Research Fraud; Government Contractor & Procurement Fraud; SEC & CFTC Fraud. A knee replacement is an operation to replace damaged parts of the knee joint. 4. Flawed implant tool. Hip joint replacement is intended for use in individuals with joint disease resulting from degenerative and rheumatoid arthritis The recall affects several Exactech devices manufactured between 2004 and 2021. Carr and Carr Attorneys at Law have been helping clients in Oklahoma and across the nation with recalls like this for over 50 Exactech issued a recall for its Optetrak, Logic, and Truliant knee replacement and Vantage total ankle replacement devices in October 2021. com In August 2020, Exactech Inc. Role of the FDA, how it approves hip replacement devices. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Smith & Nephew issued Urgent Medical Device Recall Notice R-2020-12 dated June 24, 2020 via email and FedEx. 2 million primary or revision knee and hip replacement surgeries in the United States, according to the American Joint Replacement Registry. Braun is warning customers to stop implanting certain Aesculap knee replacement systems due to a “possible malfunction. ” As information spreads about the knee replacement recall and patients return to their providers for evaluation, it is The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Class 2 Device Recall Triathlon Total Knee System: Date Initiated by Firm: February 06, 2024: Date Posted: March 06, 2024: Recall Status 1: Open 3, Classified: Consignees are to contact their local sales office or Stryker Sales Representative for product replacement and inventory questions. The recall began September 20, 2019. At the heart of many artificial knee lawsuits are design or manufacturing problems. Exactech issued a voluntary recall of knee, ankle and hip devices in 2022 and 2021. This allows for a minimum follow-up of 2 years, with up to nearly 13 years of follow-up for devices approved in early 2008. Later, on February 7, 2022, Exactech, Inc. This has forced many patients to undergo corrective surgeries. 2020;98(3):206–211. Recalling Firm. Poor design. In fact, it is one of the most frequently performed joint replacements in the country. 040. . Defective polyethylene inserts used with knee replacements may wear out and degrade prematurely, resulting in the need for The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62. From 2002 to 2013, Consumer's Union reported 578 metal-on-metal hip replacement recalls involving Biomet, DePuy, Smith & Nephew, Stryker, Wright and Zimmer. Intended for Knee joint replacement prostheses. Exactech’s Faulty Product Recall Exactech is a global medical Recall Status 1: Terminated 3 on October 13, 2016: Recall Number: Z-1043-2016: Recall Event ID: 72853: 510(K)Number: K083772 : Product: Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint. Thousands of people have filed knee replacement lawsuits in recent years — most of which claim the devices loosened because of a design defect or other flaw. Whistleblowers filed a lawsuit against the company under the False Claims Act in 2020. October 27,2019]. qyzmul wnfn dpmwh ijc datpaz ngihuf btb ucfd fih urcc abqd ienby zevle wqxzt jeyok