However, in July 2020, the U.S. Food and Drug Administration (FDA) issued a Class II recall for certain Stryker LFIT Anatomic CoCr V40 Femoral Heads. However, as required by the new California Consumer Privacy Act (CCPA), you may record your preference to view or remove your personal information by completing the form below. Drugwatch.com partners with law firms. This system included a component called the Diaphyseal Sleeve, which was found to be faulty. In 2010, Zimmer issued recalls for multiple knee components in its NexGen Knee Replacement system. February 15, 2022 Exactech has recalled about 140,000 knee and ankle replacements that were implanted in patients in the U.S. since 2004 because they can wear out early.. Patients who received one of about 140,000 Exactech knee or ankle replacements, however, are now facing a recall because their replacement joints may wear out sooner than expected. Plaintiff's four-count claim alleges product liability, failure to warn and breaches of express and implied warranty. Patients affected by faulty Exactech implants may be able to sue for legal damages. Nonetheless, the pattern of medical evidence preceding the recall notice in both instances raises questions for Exactech, attorneys, and patients. Jones DN. U.S. Food and Drug Administration. Faulty knee replacements given to more than 10,000 patients. The 2022 Exactech knee recall covers Optetrak, Optetrak Logic and Truliant knee replacements. Lawsuits blame manufacturers for selling defective devices. Exactech Lawsuit Update: October 11, 2022. The recall also includes the TRULIANT total knee replacement systems. Law360. Knee replacement lawsuits focus on device complications experienced by patients. Have your case reviewed within 24 hours. Editors carefully fact-check all Drugwatch content for accuracy and quality. Those patients may have the right to receive compensation. Below we discuss the litigation, provide the most recent August 2022 updates - including the latest Exactech recall - and what our lawyer believe the average per person Exactech settlement amounts will be. UPDATED 8/19/2022: Information about a new Exactech recall involving another 40,000 defective hip replacements has been added to this post.To find out if you or a loved one received a recalled Exactech implant, request a free case evaluation. FDA Recall Posting Date. Zimmer initiated a voluntary recall, backed up by the FDA. A doctor can help you understand your medical options. Anyone considering an Exactech lawsuit should speak with an attorney experienced in faulty medical implants. Knee implant lawsuits allow such patients to hold the manufacturer financially responsible for defective knee implants. Stryker is another company that makes knee replacement components and tools and it faced a Class I FDA recall in 2013. February 2022. Law360. According to the lawsuit, these actions led to increased educational costs. Some of the joints that have caused these problems were considered to be faulty and were the subject of voluntary knee replacement recalls. You should also talk to a lawyer before you talk to any representatives from the device manufacturer. Drugwatch is located at: Access top industry professionals with stellar credentials. The company that made a faulty, recalled joint has an obligation and responsibility to warn patients that there are problems, and if you were not warned, you may have the, MRI Contrast Agents Omniscan and Magnevist Overview, Talcum Baby Powder and Mesothelioma Overview, Talcum Baby Powder and Ovarian Cancer Overview, Talcum Baby Powder and Mesothelioma Lawsuits, Talcum Baby Powder and Ovarian Cancer Lawsuits, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm287552.htm, http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm340708.htm, http://www.fda.gov/MedicalDevices/Safety/ucm348536.htm, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=133978, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm223613.htm. If you or somebody you know has been injured by a defective knee replacement or needed surgery, you should contact our lawyers immediately for a free case consultation. In this situation, you will only pay legal fees if your case reaches a settlement or verdict. Exactech Vantage ankle replacements (1,561 sold since 2016), Exactech Vantage Ankle Replacement Lawsuit, Exactech Optetrak knee implants (60,926 sold since 2004), Exactech Optetrak Logic knee implants (60,518 sold since 2009), Exactech Truliant knee implants (24,727 sold since 2017), Lawdragon Top 500 Leading Lawyers in America. US Exactech Recall Information. This time the issue was over the safety of a component of the DePuy Limb Preservation System, or LPS. In 2011, federal lawsuits against Zimmer NexGen knee devices were consolidated into MDL 2272. After extensive testing, Exactech expanded the original August 2021 recall. Like the knee and ankle implants, no class action focused on the hip implants has yet been created. But despite the widespread use, manufacturer Exactech recently issued a recall on Exactech knee replacement . Please call us using the phone number listed on this page. Exactech DHCP Letter. Plaintiffs continue to file claims post-recall. This speeds up the process of trying hundreds of similar cases. Arthritis and other conditions can cause enough damage to the joint over time that it becomes too painful to move very much and this can lead to a significant decrease in the quality of life. Product liability lawsuits related to knee replacements differ from medical malpractice lawsuits. . Exactech knee replacement lawsuits stem from an ongoing recall caused by manufacturing mistakes. September 29, 2022. A number of patients who received these implants are having issues with them. According to Zimmer Biomet's 2018 Annual Report, the company informed the court it was finalizing a settlement that would resolve all but six of the outstanding cases in the MDL. Retrieved from, Exactech. In February 2022, Exactech, a company that manufactures knee and ankle replacement devices, issued a recall for their Optetrak, Truliant, and Vantage products after reports from consumers that the plastic inserts are defective, causing an elevated risk of device failure and health complications. We estimate that Exactech ankle implant lawsuits will have a slightly higher compensation value of around $90,000-$175,000. Exactech DHCP Letter 02.07.2022. Recalling Firm. In April 2022, a lawsuit focused on the recalled hip implants was set for trial. June 12, 2018. Zimmer Reaches Tentative Settlement in Knee-Implant MDL. Inserts that came into contact with oxygen before implantation may oxidize. It includes versions of Exactechs OPTETRAK partial and total knee replacement systems and OPTETRAK Logic total knee replacement systems. A 2012 study in the journal Orthopaedics & Traumatology: Surgery & Research found that the OPTETRAK cemented posterior stabilized knee prosthesis performed poorly approximately 2 years after implantation, despite expectations that its design would lead to better performance when compared to earlier models. Skilled in adult stem cells, medical devices, biomechanics, bacterial and mammalian cell culture, and regenerative medicine, she provides guidance on an array of topics affecting consumers. NexGen knee MDL judge to pick Bellwethers, then order mediation. Another bellwether drops out of Zimmer knee implant MDL. Knee Replacement Lawsuits | Exactech, Stryker and More. Retrieved from. The recalled knee and ankle replacements contained a plastic insert that was packaged in a defective vacuum bag that allowed oxygen to contact the plastic insert. Data from Australian, New Zealand and United Kingdom registries have shown the implant has significantly higher overall revision rates compared to other knee implants, according to the companys recall letter. We will direct you to one of our trusted legal partners for a free case review. Calling this number connects you with a Drugwatch representative. Drugwatch.com doesnt believe in selling customer information. As information spreads about the knee replacement recall and patients return to their providers for evaluation, it is likely that more instances of premature wear, related symptoms, and the need for revision surgeries will come up. Recent recalls of DePuy knee systems and components have made the news in the last two years, especially as victims of the harm caused by these systems have begun to file lawsuits against Johnson & Johnson. Knee replacement lawsuits occur when knee implants fail or are defective. The latter gives more natural movement to the joint. This website does not provide medical advice, probable diagnosis, or recommended treatments. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753. The information on ConsumerSafety.org is provided for informational purposes only and is not intended to provide specific legal advice. At the time, the company noted that the recalled implants could fail prematurely. As you perform your role, its good to have a basic understanding of the different phases of a lawsuit. Medical device implants are difficult to repair, replace or remove. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. Knee replacements surgeries may be complete or partial, depending on the extent of the damage to the natural joint. Law360. Jones, DN. Corso J. DePuy and Zimmer are two companies that have recalled knees. One is to discuss the manufacture, design, and distribution of the medical device itselfhere, the knee and ankle replacement systems. June 10, 2016. Olson E. Sulzer Offers $1 Billion Settlement for Defective Implants. The implant failures named in those lawsuits may have originated from the same packaging issue driving the current recall. However, the company has faced many more recalls before these most recent issues occurred. New York, NY 10005. The replacement of the damaged knee joint with an artificial system can help a patient to get better mobility and to reduce pain. Problems with the production of Sulzer's Natural Knee II Tibial Baseplate caused a small amount of oil to be left on the device. February 14, 2018. Without the extra protective layer, oxygen could pass through the implant packaging. Artificial knees may include the whole joint or only components depending on what the patient needs, and may be made of ceramic, metal, or plastic. Exposure to oxygen can cause the inserts to degrade over time and lead to early device failure. Updated on May 13, 2022. The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls . To date, the recall covers approximately 140,000 knee and ankle replacements manufactured since 2004. More than 10,000 patients have been given a faulty knee replacement which doubles the risk of joint failure, The Telegraph can disclose . All Rights Reserved.The Schmidt Firm, PLLC | 3500 Maple Ave, Suite 1250 | Dallas, TX 75219 | (866) 920-0753Sitemap | Privacy Policy | Disclaimer, Call Today for a FREE Confidential Case Review. According to the recall notice issued on February 7, 2022: Over time, oxidation can severely degrade the mechanical properties of [the implant], which, in conjunction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.. December 2022 Update: FDA Recalls Exactech Ankle, Hip, & Knee Replacements. Get this professional legal advice before you sign anything, as you may be asked to sign away your right to sue for damages. Nearly 1,000 implant parts used in knee surgeries have been affected by DePuy, Zimmer-Biomet and Stryker knee replacement recalls. October 2021. The patient suffered "pain, swelling, instability, and bone . Exactech Knee Patient Letter 02.07.2022. We only gather information from credible sources. 2022 CSO Technology Partners, LLC. Patients may need another surgery if they experience symptoms like new or worsening pain, inability to bear weight on the knee or ankle, grinding sounds or other noises, swelling, or . Artificial knees may also have a fixed or rotating platform. Company officials say implants lacked an important packaging barrier. However, it lacked a special layer with additional protection against oxygen. For most patients the surgery goes well and the new knee is a success. Overview of Exactech Recall. v. Exactech Inc. (1:22-cv-1027), filed in the U.S. District Court for the District of Maryland on April 26, 2022, is a . This page was fact-checked by Dr. Francis Perry Wilson, M.D. Unity Total Knee System. Lone Pine entered in Zimmer MDL admid atty finger-pointing. The most recent Exactech recall applies to more than 140,000 implanted knee and ankle replacements. Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. Get legal industry news, expert perspectives, and the latest in litigation straight to your inbox. January 26, 2016. The company had issued a recall on the knee component in 2000. Zimmer Biomet currently faces the most lawsuits, but other companies have also faced individual and class action lawsuits due to defective products. Prior to this recall, Exactech already faced Optetrak knee implant lawsuits where patients claimed the implant failed early, causing pain, instability and the need for revision surgery. The ruling by the Sixth US Court of Appeals ended 15 years of litigation. The company that made a faulty, recalled joint has an obligation and responsibility to warn patients that there are problems, and if you were not warned, you may have the right to sue and receive compensation. The product in question was the ShapeMatch Cutting Guide. The plaintiff alleged that the OPTETRAK Logic total knee replacement systems the plaintiff received in 2013 and 2015 were defective. After this, patients may need revision surgery. Breaking into Expert Witness Work:The Ultimate Guide, Techniques for WritingPersuasive Expert Witness Reports, 7 Must-Haves in YourExpert Witness Resume/CV, NY attorneys, access any defense experts litigation history, Daubert challenges, deposition transcripts, and more. Your web browser is no longer supported by Microsoft. You should also schedule an appointment with your doctor to have the surgery site observed for any damages. The damage it caused in some patients included broken bones, infections, and in some cases even amputation of the leg. Jones DN. This means tens of thousands of patients may have problems related to Exactech knee implants. In February 2022, knee and ankle device manufacturer, Exactech, issued a recall for its widely-used knee and ankle replacement implants after investigations revealed alarmingly high-rates of premature wear and complications due to improper packaging of the device prior to surgical use. Exactech doesnt recommend surgery for patients who arent experiencing problems such as pain or difficulty walking. In the event of a recall you have certain rights as the patient and recipient of the joint and you need to take steps to ensure your rights are protected. In addition, Dr. Moncivais reviews portions of medically driven content to ensure scientific accuracy. Lawsuits say Exactech knew or should have known of the problems but failed to warn consumers and continued to sell defective devices. In aletter intended for knee replacement patients, Exactech explains that the packaging for the knee replacements plastic inserts may have allowed oxygen to diffuse into the plastic insert. . Law360. Looking to file a knee replacement lawsuit? Law360. A knee replacement lawyer can help determine the best approach to legal recourse. so have the number of problems reported with knee implants. The plaintiff alleged that the OPTETRAK Logic total knee replacement systems the plaintiff received in 2013 and 2015 were defective. 2022. We bring you consulting opportunities for free. Cutting-edge medico-legal research reports, Grow your practice & increase profitability. The manufacturer, Exactech, has stated that the . Patients who suffer severe medical device complications can seek legal help. However, painful and debilitating complications can arise. All pending cases were put on hold. Recalls Background and Definitions. Recalled Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts fit in between metal components in knee and ankle replacements to cushion joints. Exactech recalled the devices because of out-of-specification packaging that didnt adequately protect the inserts from oxygen exposure, according to the companys Urgent Medical Device Correction letter sent to surgeons on February 7, 2022. A Sample Voir Dire: How To Qualify An Expert Witness, Challenging Opposing Experts: Advanced Research Techniques, Cross Examining Expert Witnesses: The Ultimate Guide, Law 101 for Experts: Understanding the Different Phases of a Lawsuit, Florida School Districts Sue McKinsey & Co. Over its Role in the Opioid Epidemic, Sounds such as grinding or clicking noises. A knee replacement is typically done for a patient who experiences enough pain and lack of mobility to make the risks of surgery worthwhile. In February 2022, Exactech issued an Urgent Medical Device Correction Notice informing surgeons that most of the Exactech knee inserts that were manufactured from 2004 until 2022 contained non-conforming packaging layers on the part of the device that fits between the femoral component and tibial . Zimmer Biomet is the biggest knee replacement company on the globe. Exactech sent a recall notice to surgeons across the US on February 7, 2022. Additionally, the company recalled 1,561 units of Exactechs VANTAGE Fixed-Bearing Linear Component total ankle replacement systems. Advertisement. Salvatore C. Jury clears Zimmer in hip-implant suit. Some of the brands involved in complex litigation include: Individuals who have suffered complications from these devices should consider legal action. (2022, February 7). She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and womens health issues. In addition, the knee replacements could crack or fracture, cause bone loss, or lead to other problems that might require patients to undergo additional surgery. Jones DN. 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The recall was issued due to reports of taper lock failure and dissociation. Because medical device cases can be complex, clarity is vital. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts. If you find any errors, please let us know using our contact form. Some of her qualifications include: Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); 48 Wall Street, 16th Floor This "Lone Pine" order required claimants to "provide evidence or certification of loosening of a NexGen Flex femoral component, a 5950 NexGen MIS Stemmed tibial component, or any other tibial component implanted with a NexGen Flex femoral component." In July 2022, researchers reported on a clinical study that followed a group of adults aged 45 to 74 for five years after they . Learn how artificial knee joints work, who are the best candidates for surgery and possible complications. Multidistrict litigation (MDL) is another method that courts use to merge lawsuits. However, certain phases of litigation are combined for all the lawsuits. In fact, the 2021 Exactech recall covers Optetrak devices, which also garnered lawsuits as far back as 2017. The filed claims are still in the early stages. In October 2017, a plaintiff in the Northern District of Alabama filed acomplaint against Exactech. An on-demand consultation can provide benefits at any stage in ones case. Exactech recently issued a recall notice for Optetrak, Optetrak Logic and Truliant knee replacements. Exactech knee implants contain a component referred to as an. Once the bandage is removed, tubigrip compression bandages can be used to help reduce the swelling and support the knee. Tara September 21, 2022 at 1:13 pm. In February 2022, Exactech recalled over 100,000 plastic inserts that were used in their knee and ankle replacements after discovering that the plastic can wear out early, causing the implant to fail and requiring corrective surgery. Shes an experienced Regenerative Medicine Consultant with a demonstrated history of working in the hospital & healthcare industry. The patient suffered pain, swelling, instability, and bone loss in both knees caused by early and accelerated polyethylene wear and component loosening. Eventually, the patient had extensive revision surgery on both the right and left knee. In the event of a recall you have certain rights as the patient and recipient of the joint and you need to take steps to ensure your rights are protected. The FDA classified the recall as a Class 2 recall. Theres no charge and no legal obligation. Insights into the legal process and procedures will help you see your role in the larger context of a lawsuit. This barrier was supposed to keep oxygen from coming in contact with the inserts. The list of knee replacement recalls for 2017 below consists of only FDA recalls. The compensation may fall well short of what you need to cover your additional expenses, not to mention any income you may have lost from being forced to miss work. Exactech. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. Plaintiffs seek legal damages related to medical bills, pain and suffering related to their faulty knee implants. There is usually swelling around the knee for the first few days after surgery. Radiolucent lines can cause serious complications including getting debris lodged in the gap, bone damage, selling and pain, and ultimately failure of the entire artificial knee. U.S. Food and Drug Administration. If you have an artificial knee you should be aware of all recalls in case your knee is the subject of one. It is possible more recall lawsuits could be filed in the future. A component of a knee replacement product known as the Persona total knee replacement system has been recalled by the manufacturer. Following reports of premature wear and early revision surgery, an Exactech recall was issued this month, impacting more than 147,000 knee implants and . Patients may also experience symptoms in the affected joint that include: Ankle replacement systems are expected to last 10 to 20 years with normal use. Stryker attempted to get its excess liability insurance company, TIG Insurance, to pay for . Class 2 Device Recall OPTETRAK Comprehensive Knee System. These cases are also potential reasons for a revision surgery. Over the years, many lawsuits have been filed against knee device makers including: Due to the volume of lawsuits, many of these cases were consolidated into multidistrict litigation. Our writers use only legitimate, authoritative sources including government websites, legal authorities, medical society publications, and peer-reviewed medical journals. (2022, February 7). Review our editorial policy to learn more about our process for producing accurate, current and balanced content. Prior results do not predict a similar outcome. Knee replacement is a growing trend in the U.S. Please read our disclaimer for more information about our website. In March 2022, a plaintiff in the Southern District of New York filed acomplaint against Exactech. Exactech recalled the devices because of out-of-specification packaging that didn't adequately protect the inserts from oxygen exposure, according to the company's Urgent Medical . . These devices were surgically implanted from 2004 through 2022. These manufacturing mistakes may make some knee replacements fail early. Exactech issued a recall for thousands of polyethylene plastic inserts used in knee and ankle replacements because the plastic may wear early, leading to implant failure and revision surgery. Sorry there is a continuing error in our system. The Schmidt Firm, PLLC is currently accepting Exactech knee replacement induced injury cases in all 50 states. Some of the artificial knees and other products made by the company had been redesigned and released without approval from the FDA. Patients who undergo joint replacement surgery expect their new hardware to last for many years. According to this notice, doctors have implanted more than 140,000 of these knee devices since 2004. Exactech first announced a recall in August 2021. In August 2021, the U.S. Food and Drug Administration (FDA) announced a recall of a variety of Exactech knee and ankle replacements with polyethylene components and inserts, due to risk of device failure that could lead to health risks and require corrective revision surgery. American Joint Replacement Registry. Source: U.S. Food and Drug Administration Recall Database. Access exclusive educational content and resources. The U.S. Food and Drug Administration keeps a recall database for medical devices. Retrieved from, Exactech. The sleeve is inserted into the leg bone to support the reconstruction, but the FDA found that DePuys Diaphyseal Sleeve was inadequate to support the load put on it and it had to be recalled. Knee replacement recalls have been issued because of loosening, early wear or faulty packaging. Law360. Copyright 2020 The Schmidt Firm, PLLC. Pressure to form a class of those injured by the knee and ankle replacement systems will mount as more injury cases surface. This site complies with the HONcode standard for trustworthy health information: Verify here. A knee replacement can completely turn that around if it goes well, and for most patients it does. Consultations with qualified physicians through Case Clinics can help attorneys gain this clarity and explore essential issues. Sorry there was an error. Annual Report 2018. Zimmer Biomet Holdings, Inc. 2019. Zimmer NexGen MDL Nears Finish with Confidential Deal. Your pain and suffering should also be considered, as well as any loss of mobility you experienced from a faulty knee replacement. Zimmer replaces 2nd bellwether suit over knee implants. Speaking to an Arkansas Exactech recall lawyer can also help . A June 2020 study in Arthroplasty Today examined 204 primary total hip arthroplasty procedures. Stryker Knee Replacement Lawsuit and Settlements. New York Times. Law360. The company cited a risk of edge-loading and premature prosthesis wear in relation to this recall. Some devices have been recalled by manufacturers because they caused so many problems for patients. Some patients may require revision even before the five-year mark. Plaintiffs continue to file claims post-recall. Patients who suffer serious side effects may require additional surgeries or other treatments. Early deterioration of Exactech knee implants may cause: These problems may require patients to undergo revision surgery, which can be costly. Health care providers may contact patients who received these devices to make sure that the devices are working properly. More than 1,700 Zimmer lawsuits were filed in the MDL before trials began in 2015. 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. This is one component of the Persona artificial knee system and was recalled because of reports of adverse events. Lawsuit verdicts or settlements may help these patients cover revision surgery and other related costs. (2022, February 7). Johnson & Johnson Lawsuits Every Person Should Know About, Legal Look: DePuy Hip Settlements, FTC v AbbVie, Lax Clinical Trials, and Why Juries Matter. Please wait a moment and try again. (2022, February 7). If you or a loved one has used these knee implants and experienced looseness, pain or discomfort from the implant, please call one of our knee replacement attorneys at 800-553-8082 or click here for a free no bligation consultation on your potential knee lawsuit. Join our newsletter to stay up to date on dangerous drugs and devices, keep up on lawsuit and settlement news, learn about FDA recalls, and more. Many of these complications are caused by defective design or manufacturing. Arbitration is often used in an attempt to reach a settlement. Oxidation in the Exactech systems, however, may lead to a need for revision surgery in as little as five years. No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753. The plaintiff alleged that the patients receipt of an OPTETRAK knee implant resulted in injuries. The implants were recalled because they can fail prematurely, crack or fracture, cause bone loss, or other problems that require surgery. US Recall Information, Knee/Ankle. ALL RIGHTS RESERVED. We appreciate your feedback. If your Exactech knee or ankle replacement was recalled, you should contact a lawyer for mass tort cases immediately to seek justice and to get the compensation you deserve. The letter asks patients to return to their treating provider for evaluation. However, a class action is one possible course the litigation may take. Protect your rights first and make sure you get what you deserve. On February 7, 2022, Exactech issued a letter to patients and surgeons recalling over 147,000 of its knee and ankle replacement devices. In July 2021, Exactech also announced a recall of its Connexion GXL acetabular polyethylene hip implant liner. If you are facing a recall, make sure you talk with a lawyer to discuss your rights and your options. The recall involves the following implants: Patients may experience symptoms like new or worsening pain, inability to bear weight, grinding or other noise, swelling, or instability in their knee or ankle. The implants were recalled because they can fail prematurely, crack or fracture, cause bone loss, or other problems that require surgery. 1 South Orange Ave, Suite 201, Orlando, FL 32801. Knee Swelling. The complaints included loosening of the plate in the joint and radiolucent lines. In June 2016, Judge Rebecca R. Pallmeyer issued a case management order that threw out cases regarding claims other than device defectiveness. All lawsuits involving the recalled Exactech knee replacement or ankle replacement implant systems will now be centralized in the Eastern District of New York. Periprosthetic joint infection (PJI) is a devastating complication of knee and hip replacement surgery that can, in some cases, be difficult to distinguish from other causes of arthroplasty failure. Most notably, on February 22nd, Zimmer Biomet was issued a total of 5 recall orders pertaining to their Oxford product line due to potential alumina inclusion in the finished product that could lead to cracking and separation. In January 2018, Judge Pallmeyer ordered both sides of the NexGen Knee Systems lawsuits to attend arbitration. July 2014. 'It was a constant battle to keep the swelling down and . The companies with the most recalls have also faced significant numbers of lawsuits: Exactech has issued at least 47 recalls since 2003. Swelling is one of the most common knee replacement problems. on April 02, 2019 to ensure that it meets our rigorous editorial standards. The knee and ankle replacement recalls and related lawsuits are not the first Exactech has faced. Zimmer Knee Replacement Recall. Exactech initiated the recall in August 2021, but after extensive testing, the company determined that a significantly larger number of implants manufactured since 2004 would also need to be recalled. This was a disposable cutting guide designed to be used just once by a surgeon to guide and mark a bone before cutting it to fit the replacement knee. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Another is to explore the effects of premature wear on the body, including the link between the wear and the patients reported symptoms. Update your browser for more security, speed and compatibility. At that time, each patient and their provider can determine the appropriate next steps based on the condition of that patients implant, the implantation site, and overall health. The JPML has officially consolidated the Exactech joint replacement recall lawsuits into a new class action MDL. Many of these problems occur because of defective knee devices. It is not a substitute for professional medical advice, diagnosis or treatment. For more information, visit our partners page. According to the recall, their products were stored in vacuum-sealed bags that allowed oxygen to . The company initiated the recall of its own product because it found that the Cutting Guide did not match up with the parameters that surgeons were entering into the tools web application prior to surgery. Drugwatch's trusted legal partners support the organization's mission to keep people safe from dangerous drugs and medical devices. The recall followed high-rates of wear and complications due to suspected improper packaging. The recall covers all knee and ankle inserts packaged in out-of-specification bags regardless of label or shelf life. The company confirmed that inserts manufactured since 2004 were packaged in out-of-specification bags, and about 147,732 devices have been implanted in the US since 2004. Below is a partial list of the awards and recognition that the attorneys / lawyers at our law firm have been awarded with, as well as a list of professional memberships. This is one component of the Persona artificial knee system and was recalled because of reports of adverse events. Katy Moncivais holds a Ph.D. in Biomedical Engineering from The University of Texas at Austin. Your email address will not be published. May 5, 2017. Exactech Knee Replacement Lawsuits. Required fields are marked *. The information on this website is proprietary and protected. This "accelerated polyethylene wear" was causing a "statistically significant" rate of component failure and revision . These lawyers can help potential plaintiffs determine the best legal approach for their case. Over 28,000 individual joint components were . In February, the two sides came back with a proposed settlement offer. March 28, 2016. If you would like to speak with a Drugwatch representative, please call 888-645-1617. Our primary focus in 2022 is on the Exactech Optetrak. Recalls often come with compensation for the patients affected, but you may be entitled to more than what the company is offering. In 2015 the FDA announced a Class II recall of a Zimmer knee product, the Persona Trabecular Metal Tibial plate. Claimants who failed to do so within the specified time frame had their cases dismissed. The latter are gaps between the artificial knee and the natural bone. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website. It has had 377 separate recalls since 2003, and, again, this number reflects separate brands being recalled, not the number of individual pieces that were pulled off the market. Exactech Total Knee Replacement Device Recall. Pundit and former footballer Jamie Redknapp has undergone knee replacement surgery after having 'constant problems' since he was 18. At the heart of many artificial knee lawsuits are design or manufacturing problems. If you have an artificial knee you should be aware of all recalls in case your knee is the subject of one. Used for knee prosthesis in total knee replacement: 2 11/21/2022 Corin Ltd Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in . Reuters. Learn about your legal options and get free evaluations from attorneys experienced with product liability and personal injury cases. Putnam County school board leads the Florida class action, Your email address will not be published. In rare move, judge orders Zimmer plaintiffs to prove cases. Any unauthorized or illegal use, copying or dissemination will be prosecuted. A missing oxygen barrier in the device packaging may have caused these implants to break down. November 6, 2015. The disadvantages of knee replacement surgery include wear in artificial knee joints, complications involving anesthesia, deep vein thrombosis, infection, as well as knee stiffness and loss of motion, to name a few. Exactech's recall acknowledges that all knee and ankle replacement products made since 2004 were defective and subject to high failure rates. Long before the NexGen lawsuits, Sulzer Medica paid $1 billion to settle about 4,000 knee device lawsuits. This website and its content may be deemed attorney advertising. And although the procedure can be done if necessary, revision . If you received a faulty Exactech knee replacement, you should speak with a doctor and a lawyer right away. In March 2022, a plaintiff in the Southern District of New York filed a complaint against Exactech. Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. And, defective medical devices still face regular recalls. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent. Contact Us Today for a Free Case Evaluation. Exactech. Fifth AJRR Annual Report on Hip and Knee Arthroplasty Data. Learn more about medical device recalls. In 2015 the FDA announced a Class II recall of a Zimmer knee product, the Persona Trabecular Metal Tibial plate. The complaint also alleged that By at least April 2008, Defendants became aware of a high rate of early failures with the finned Optetrak products, requiring additional revision surgeries. 2 11/22/2022 MicroPort Orthopedics Inc. Exactech knee implants have been recalled due to faulty packaging that was used during shipment and storage. The study found 5 cases of severe polyethylene wear and osteolysis which occurred within 5 years of the index surgery. The researchers not only noted these numbers were a concerning trend but also stated that further investigation is warranted to evaluate material characteristics which may have caused this accelerated wear and to prevent recurrences of this complication in the future. A September 2020 letter to the editor in The Journal of Arthroplasty raised similar concerns. Compensation for legal damages might help patients pay for treatment related to their recalled knee implants. This settlement came before the company was acquired by Zimmer in 2003. One of the companies that makes artificial knee systems and one that has faced recalls is DePuy. Were serious about providing trustworthy information that meets our publishing standards. Exactech Ankle Patient Letter. Exactech knee replacements have been involved in litigation for years now. Attorney Advertising. Although Exactech announced the recall in 2021, evidence of problems with its products was mounting before that date. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. Stryker Corporation was required to pay a $7.6 million product liability settlement in 2016 for the Duracon Unicompartmental Knee. The most important news about the Exactech lawsuits came in the fall of 2022 when courts in Florida and New York agreed to consolidate individual Exactech knee and hip replacement lawsuits into MDLs. One of our content team members will be in touch with you soon. Revision surgery is typically needed when radiolucent lines develop. Law360. Zimmer Biomet. Call our defective medical device lawyers at (888) 424-5757 (toll-free phone number) or use the contact form today for immediate legal advice and schedule a free consultation related to your Exactech lawsuit. Written by Dani Alexis Ryskamp, J.D. The agency accused DePuy of marketing and distributing products that had not yet been approved. In its recall notice Exactech, said that the recalled knee implants were packaged in "out-of-specification" vacuum bags. Patients with recalled Exactech knee or ankle implants suffering from new or worsening swelling, pain while walking, inability to bear weight, grinding or other noise, instability or any new symptoms of clicking in the knee or ankle should contact their providers for an evaluation. As with many medical device product liability claims, attorneys will likely call upon experts in several areas. Potential problems caused by Exactechs recalled knee and ankle implants include: Accelerated wear, debris production, bone loss, component fatigue and component cracking or fracture that will require revision surgery to correct. Smith & Nephew's first-generation knee replacement device was recalled on Oct. 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.. Smith & Nephew's JOURNEY Bi-Cruciate Stabilized (BCS) Knee system was the first-generation version of the JOURNEY II BCS which replaced the . Exactech Knee Patient Letter. EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base . The 2022 Exactech knee recall covers Optetrak, Optetrak Logic and Truliant knee replacements. The recall came after a warning letter from the U.S. Food and Drug Administration (FDA) in 2011. Unlike a class action lawsuit, individual cases remain separate in an MDL. June 1, 2016. Boarding & Prep School Sexual Abuse Lawsuit, medical device complications can seek legal help, Another bellwether drops out of Zimmer knee implant MDL, Zimmer knee implant cases will move forward as MDL, Zimmer wins first U.S. trial over NexGen Flex knee devices, In rare move, judge orders Zimmer plaintiffs to prove cases, Lone Pine entered in Zimmer MDL admid atty finger-pointing, Zimmer gets win in 3rd knee implant bellwether, Zimmer replaces 2nd bellwether suit over knee implants, NexGen knee MDL judge to pick Bellwethers, then order mediation, Sulzer Offers $1 Billion Settlement for Defective Implants, Zimmer NexGen MDL Nears Finish with Confidential Deal, Zimmer Reaches Tentative Settlement in Knee-Implant MDL, Class 2 Device Recall OPTETRAK Comprehensive Knee System, Stryker ShapeMatch Cutting Guides (not a knee joint component itself, but a tool used in knee surgery). The Schmidt Firm, PLLC has been recognized as one of the nations leading plaintiffs' law firms and handles cases in all 50 states. Knee replacement surgeries are generally considered safe. As details about the NexGen implant problems were made public, people who suffered pain, discomfort and immune system reactions to their knee implants began filing lawsuits against the company. By June 2016, a single bellwether trial was complete and 15 others had been dismissed. Patients may receive knee implants during knee replacement surgery, also known as total knee arthroplasty. Biomet recalled its Regenerex Series A Patella knee replacement device in 2017. Like DePuy, Zimmer Biomet had a big recall in 2017. It starts with our strict sourcing guidelines. If the implants are defective, patients may experience negative side effects or implant failure. In February 2022, medical device manufacturer, Exactech, issued a recall for its knee replacement implants. As a result, patients harmed by faulty Exactech knee implants are suing the manufacturer. Dye J. Zimmer wins first U.S. trial over NexGen Flex knee devices. The result was the possibility of excessive oxidation of the. The recall affects tibial inserts and liner components from the following knee and ankle replacement systems: Optetrak, Optetrak Logic, Truliant and Vantage. Optetrak and Optetrak Logic Knee Replacement, Truliant Knee Replacement, NexGen Knee Replacement System, Attune Knee System, Duracon Unicompartmental Knee, ShapeMatch Cutting Guides, Exactech, Zimmer Biomet, Depuy Synthes, Stryker, To replace knee joints in patients with a variety of degenerative knee conditions, Pain, aching, inflammation, infection, swelling, device loosening, clicking or popping, impaired mobility, metal allergy, metallosis, revision surgery. Surgeons had to manually correct the parameters and this resulted in cutting ranges not approved by the FDA. This was an important step for the litigation, as an MDL both acknowledges and anticipates large numbers of claimants joining the lawsuits. In 2013 DePuy faced another recall when the FDA issued another warning. These estimates are based on the average compensation payouts in other tort cases involving serious knee and . Depending on the severity of side effects, recipients of faulty knee implants may require costly medical care or additional surgeries. The result for some patients could have been fractures, pain, limited mobility, instability in the joint, and a need for revision surgeries. February 15, 2022 Exactech has recalled about 140,000 knee and ankle replacements that were implanted in patients in the U.S. since 2004 because they can wear out early. In February 2022, Exactech recalled about 147,000 plastic inserts that were used in knee and ankle replacements because the plastic can wear out early, leading to failure of the implant and corrective surgery.. Several of the first few cases selected for bellwether trials were dismissed before they went before a jury. May 25, 2017. Some of these difficulties are forcing patients to have corrective surgery, which is also called revision surgery. . DePuy Recalls Before 2015. The FDA at the time of the recall announcement had received 44 reports of incidents related to the faulty tool. February 2022. This led to post-implantation problems and adverse effects following the surgery. Drugwatch has a stringent fact-checking process. A reputable lawyer can also take your case on a contingency basis, meaning you will have zero upfront costs. December 1, 2022 - Exactech Recall information Update. In June 2018, the plaintiffs' lawyers announced a settlement agreement with Zimmer Biomet over NexGen lawsuits. This means the recalled products may cause temporary or medically reversible health issues. A class action lawsuit has not yet been organized for plaintiffs alleging injuries from the recalled knee or ankle implants. Example of Recent Exactech Knee Implant Lawsuit The case of Rex Foxwell, et al. The site is sponsored by law firms. Details of the settlement remain confidential. Knee replacement 2019 need revisional surgery can barely walk and fall along can't work. Keep people safe from potentially harmful drugs, medical devices and procedures by informing them of medical conditions, severe side effects and ways to take action. March 16, 2017, Corso J. Zimmer knee implant cases will move forward as MDL. The notice warned that defective packaging might lead to the premature deterioration of some parts of the Exactech knee replacement system. Lexis Legal News. As of September 2020, there is no recall on Stryker knee replacements. 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