Exactech has issued several recalls on its joint replacement devices. Click the links below for information on a recalled device:
– Exactech Knee and Ankle Devices Recalled Following Alarming Failure Rates
– Exactech Hip Replacement Devices Recalled Twice Following Alarming Failure Rates
Defective Medical Device Lawyers Handling Claims Involving Exactech Recall Joint Replacements Lawsuit
Burg Simpson is investigating claims on behalf of individuals who sustained serious injuries as a result of Exactech knee replacements, ankle replacements, and hip replacements. You may be entitled to compensation if you suffered any of the following after receiving one of these devices:
- Swelling of the joints
- Pain
- Inability to bear weight
- Grinding
- Instability
- Clicking
- Device loosening or failure
Compensation may be available to pay for revision surgery and other costs associated with malfunctioning Exactech knee, ankle, and hip replacement devices. A knowledgeable defective medical device lawyer at Burg Simpson can help with your claim!
Please fill out the form on this page or call 888-895-2080 today for a FREE consultation. Burg Simpson handles dangerous drug and medical device claims on behalf of clients nationwide.
Exactech Knee and Ankle Devices Recalled Following Alarming Failure Rates
In August 2021, Exactech initiated a Class 2 Recall of multiple knee and ankle replacement devices:
- OPTETRAK Knee
- OPTETRAK with Logic Components Knee
- TRULIANT Knee System
- VANTAGE Ankle Systems
These Exactech knee and ankle replacements have plastic components made of Ultra High Molecular Weight Polyethylene (UHWMPE). The plastic components are supposed to be packaged and distributed to hospitals and/or surgeons in oxygen-resistant vacuum bags that contain a secondary barrier. This second barrier contains ethylene vinyl alcohol (EVOH) – a compound that assists in keeping oxygen away from plastic components.
Exposure to oxygen can cause a process called oxidation. Over time, oxidation can damage the structural integrity and mechanical properties of the plastic components of these knee and ankle devices.
Since 2004, Exactech has been distributing these plastic components in bags that failed to meet required specifications. These bags did not contain the secondary barrier to protect from oxygen exposure and subsequent oxidation.
In the company’s letter to doctors explaining the Exactech recall, the company suggests oxidative damage to the plastic components may accelerate “wear debris production and bone loss, and/or component fatigue/cracking/fracture all leading to corrective revision surgery.”
Currently, the Exactech recall involves over 147,700 improperly packaged Exactech devices subject to oxidation have been implanted in patients across the United States. Data from European and Australian medical device registries have reported higher than expected rates of failures and revision surgeries for the OPTETRAK Knee System. Although the exact root cause has not been determined, Exactech has acknowledged that out-of-specification packaging causing oxidation to the plastic components may be related to these failures.
How Burg Simpson Can Help With Your Exactech Recall Lawsuit
Our mass tort attorneys are highly experienced in medical device litigation. We have the resources and experience to handle complex lawsuits and help get you the compensation you deserve.
If you or a loved one has suffered injuries and required revision surgery due to a dangerous medical device such as the OPTETRAK Knee System, OPTETRAK Logic Knee System, TRULIANT Knee System, or VANTAGE Total Ankle System, call us today at 888-895-2080.
Exactech Knee and Ankle Devices Recalled
Certain lots of the following Exactech knee and ankle devices are subject to this recall:
- OPTETRAK Comprehensive Knee System with All-Polyethylene Tibial Components
- OPTETRAK Comprehensive Knee System with HI-FLEX Polyethylene Tibial Components
- OPTETRAK Comprehensive Knee System with OPTETRAK Logic All-Polyethylene Tibial Components
- OPTETRAK Comprehensive Knee System with OPTETRAK Logic Modular Tibial Components
- VANTAGE Total Ankle System with Fixed-Bearing Polyethylene Liner Component
- TRULIANT Knee System with TRULIANT Tibial Inserts
If you have your device serial number, you can search your serial number on Exactech’s website to determine if your device is subject to an Exactech recall lawsuit.
Real-World Data on OPTETRAK Knee Systems
The OPTETRAK Knee System was introduced in 1992 and has been used throughout the world. In many countries, long-term follow-up of patients and patient outcomes are monitored by medical device registries.
In Australia, follow-up with patients receiving total knee replacements with the OPTETRAK system showed a significantly higher revision rate when compared to other companies’ total knee replacement systems. This means more patients who received OPTETRAK needed to have a second surgery to fix or repair the failure of their Exactech knee replacement. A similar finding was observed in the United Kingdom registry. In the New Zealand medical device registry, data showed 9.5% of patients with a primary OPTETRAK total knee replacement required a revision.
Exactech has acknowledged that the data in these medical device registries of required revision surgeries for their recalled knee devices were related to accelerated UHMWPE/polyethylene wear which occurred at higher rates than other companies’ total knee replacements.
FAQ Supplement for Exactech Hip, Knee, and Ankle Device Recall
What Are the Common Signs of Failure in Exactech Joint Replacements?
Symptoms of failure in Exactech knee, hip, and ankle replacements typically involve issues related to the joint where the device was implanted. These symptoms can include:
- Swelling of the Joints. One of the first signs of a failing joint replacement is often swelling around the joint area. This swelling may be due to inflammation caused by the body reacting to the failing device.
- Pain. Patients may experience persistent or increasing pain in the joint. This pain may be a result of the device loosening, misalignment, or wear and tear of the components.
- Inability to Bear Weight. If the joint replacement is failing, patients might find it increasingly difficult to bear weight on the affected limb. This could severely limit mobility and impact daily activities.
- Grinding, Instability, and Clicking. Sensations of grinding or clicking, along with feelings of instability in the joint, can indicate that the components of the replacement are not functioning properly. These symptoms might suggest that the parts are wearing down or have become loose.
- Device Loosening or Failure. In more severe cases, the device itself may loosen or fail. This can lead to significant discomfort and might require corrective revision surgery.
Individuals with Exactech knee, hip, and ankle replacements need to monitor for these symptoms and consult a healthcare professional if they experience any concerns. Timely intervention can prevent further complications and determine if a revision surgery is necessary.
How Can I Check If My Exactech Device Is Part of the Recall?
The first step in determining if your device is part of the Exactech knee replacement recall is to identify the specific details of your device. This typically includes the model and serial number of the implant. This information is usually provided in your medical records or implant card given to you after the surgery.
Once you have determined which Exactech device you are using, visit Exactech’s website to take advantage of their Recall Serial Number Checker. This tool will indicate whether your specific device is part of the recall.
If you are unsure about your device details or cannot access the online tool, it’s advisable to consult with the surgeon who performed your implant surgery. They can provide information about your implant and guide you on whether it is part of the recall. Be sure to also keep an eye on updates from Exactech and the FDA regarding the recall. These Exacatec knee replacement recall updates can provide additional information about affected devices and guidance for patients.
If your device is part of the recall, it’s important to discuss next steps with your healthcare provider. This may include monitoring for symptoms, regular check-ups, or, in some cases, revision surgery.
What Should I Do If I Have a Recalled Exactech Device?
If you discover that you have a recalled Exactech device, you will want to:
Consult with Your Healthcare Provider
The first step should be to schedule an appointment with your surgeon or healthcare provider. They can assess the condition of your implant and advise you on the best course of action. In some cases, this is as simple as keeping an eye on the device to monitor for future signs of failure.
Monitor for Symptoms
Be vigilant about any symptoms that might indicate device failure such as pain, swelling, instability, or difficulty bearing weight in the affected joint. Immediate medical attention is required if any of these symptoms are present.
Stay Informed and Keep Records
Keep yourself updated with information from Exactech and regulatory bodies like the FDA regarding the recall. Maintain a record of your medical appointments, symptoms, and any communications related to your implant. This documentation could be important for medical and legal purposes.
Explore Legal Options
If you’re experiencing complications due to the recalled device, you may be entitled to compensation for all related damages through an Exactech knee replacement lawsuit. At Burg Simpson, our experienced defective medical device lawyers understand the complications that can follow Exactech device failure. We are here to assess your claim, help you understand your options, and guide you toward the most appropriate path for your case.
What Compensation Might Be Available for Exactech Device Failures?
Compensation for failures of Exactech knee and ankle devices generally falls into one of two categories—economic and non-economic—reflecting the range of impacts these failures can have. These may include:
- Medical Expenses. This can include costs for additional surgeries, hospital stays, medications, physical therapy, and any other medical treatments required as a direct result of the device’s failure.
- Lost Wages and Earning Capacity. If the device failure results in an inability to work, compensation should include wages lost while away from work, along with lost future earning capacity if the injury impacts long-term employment prospects.
- Pain and Suffering. Compensation for pain, suffering, emotional distress, and loss of quality of life are also commonly sought following medical device failure. These damages recognize the physical and emotional impact beyond the financial costs.
The specifics of compensation depend on individual circumstances and the laws of the jurisdiction where the lawsuit is filed. Burg Simpson is a national law firm with six regional offices, giving us access to resources not all firms have. During your FREE and confidential case review, we will carefully evaluate your claim to help you understand which damages you may be entitled to seek.
Is There Urgency in Filing an Exactech Recall Lawsuit?
Legal claims are subject to time limits known as the statute of limitations. These laws set the deadline by which you must file a claim, but vary—often widely—by state. If you miss this deadline, you may be barred from pursuing legal action and seeking compensation, regardless of the merits of your case.
Some statutes of limitations provide two or more years to take legal action. In some states, however, you only have one, making swift action important. Moving quickly can also help with:
- Preserving Evidence
- Preventing Further Harm
- Ensuring Swift Compensation
The sooner an Exactech recall lawsuit is filed, the quicker you may be able to receive compensation for medical expenses, lost wages, pain and suffering, and other damages. Delaying legal action can prolong the period of financial uncertainty, especially if you are facing significant medical costs.
It should be noted that, while swift action can help, it is advisable to speak with an attorney even if you believe your time limit for taking legal action has expired. There are numerous exceptions to the statute of limitations in most states, giving plaintiffs opportunities beyond the initial period to seek fair and full compensation.
Why Choose Burg Simpson for My Exactech Recall Lawsuit?
Burg Simpson is a law firm devoted to securing compensation for the victims of serious injury. We offer:
A Proven Track Record With a National Reach
With over 40 years of service and more than $2 billion recovered for our clients, Burg Simpson has enjoyed significant success in a wide range of legal matters. These include personal injury, commercial litigation, and product liability cases. Our national scope enables us to handle complex lawsuits across the United States, leveraging our knowledge of state laws and resources to protect our clients’ rights and interests.
Award-Winning Team of Attorneys
Burg Simpson’s team includes some of the most experienced and results-driven attorneys in the country. Our lawyers have been recognized with numerous awards—such as inclusion in the Best Lawyers in America Directory—for their experience and results. We have also been recognized by U.S. News & World Report as one of the Top Law Firms in the country. This high level of recognition has been consistently earned through our firm’s ability to handle complex legal matters quickly and effectively.
Client-Centered Approach and Community Commitment
Founded with a mission to fight for everyday people, Burg Simpson prioritizes honest and compassionate legal guidance, ensuring our clients are well-informed and supported throughout their legal journey. We are fully committed to helping victims of defective medical devices get the compensation they truly deserve.
Exactech Hip Replacement Devices Recalled Twice Following Alarming Failure Rates
Following higher than normal failure rates, the Exactech recalls issued affects the following hip replacement devices:
- Connexion GXL
- MCS GXL
- MCS Conventional UHMWPE
- Novation GXL
- Novation Conventional UHMWPE
- Acumatch GXL
- Acumatch Conventional UHMWPE
- Exactech All Polyethylene Cemented Cup
Exactech issued the first recall in July 2021 after receiving reports of failure due to early signs of wear on the polyethylene components of its devices. Exactech expanded this recall in August 2022 to include additional hip devices after finding that many of its hip devices had been improperly packaged without a specified oxygen barrier since 2004.
As with the Exactech knee and ankle replacement device recalls discussed above, the company acknowledges that improper packaging of its hip devices can cause oxidative damage to the components of the recalled hip replacement devices. This can result in osteolysis (progressive degeneration) of the proximal femur and the socket of the hip bone (i.e., the acetabulum). This can result in pain, loss of mobility, and an increased risk of failure and/or fracture of the hip device. Accelerated wear also tends to require surgery to replace the failed device and repair the damage it caused to surrounding bone and tissue.
What’s My Next Step?
If you or a loved one has been injured by a recalled Exactech hip, knee, or ankle replacement, act now and contact Burg Simpson. You have limited time to file an Exactech recall lawsuit after your injury. If you wait too long, you may not be able to secure just compensation for your injuries.
Call Burg Simpson today at 888-895-2080!
We offer a free, no-obligation case evaluation. We pay the cost of obtaining your medical records, any expert reviews, and court filing fees. We only receive a fee for our work if the medical device company pays your claim.
Why Choose Burg Simpson for Your Medical Device Claim?
Good Lawyers. Changing Lives.®
With our resources and experience, we can provide the level of service that smaller firms often cannot match while still retaining the personal touch you deserve. We maintain close relationships with many other national law firms and expert consultants to ensure we can offer you quality legal representation.
Burg Simpson has more than 65 lawyers and has helped more than 10,000 clients in our 40-year history. Burg Simpson was named a #1 Products Liability Law Firm in the U.S. by Martindale-Hubbell.
If you or a loved one has been injured by a recalled Exactech knee, ankle, or hip replacement device, contact one of our experienced mass tort lawyers today by calling 888-895-2080 or filling out our FREE case evaluation form.
