Knox Boteler – Boteler Richardson Wolfe
(April 6, 2022) Medical device company Exactech, Inc has issued a recall for thousands of devices used in knee, hip, and ankle replacements. The plastic may wear early, leading to implant failure and revision surgery. Now patients who had an Exactech hip, knee or ankle device surgically implanted and experienced an early failure event can file claims against Exactech for compensation.
In a formal announcement February 7, 2022, Exactech directed orthopedic surgeons and facilities to notify patients immediately if their procedures involved the Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts. The devices fit in between metal components in knee and ankle replacements to cushion joints. When defective, the failing device may result in joint stiffness, pain, and degeneration of bone requiring revision surgery. As an FDA Class II Medical Device Recall, use of the product “may cause temporary or medically reversible adverse health consequences.”
What are Exactech Joint Replacement Systems?
Exactech is a global medical device company based in Gainesville, FL specializing in surgical implants specific to joint replacement surgeries. In 2021, Exactech announced troubling findings with its line of hip, knee, and ankle arthroplasty polyethylene inserts. These systems have been used in more than 150,000 knee, hip, and ankle replacement surgeries since first introduced in 2004.
Why Your Exactech Joint Replacement Could Fail
In its February statement, Exactech said its recall was based on non-conforming packaging that failed to protect the devices from early exposure to oxygen. Vacuum-seal bags were defective, allowing exposure and potential oxidation of the polyethylene liners used in many of Exactech’s hip, knee, and ankle devices. The resulting premature breakdown may lead to a broad range of serious discomfort demanding correction by revision surgery.
What’s the Solution if I Have a Failing Exactech Device?
A failed insert component may begin to degrade, fracture or crack over a short period of time relative to typical implant devices. Joints may become stiff and painful, eventually requiring corrective revision surgery. According to the American Association of Orthopedic Surgeons (AAOS), successful knee and hip replacements last 10-20 years for 90% of patients. Studies involving the Exactech products found a much higher rate of failure.
While revision surgery would be the corrective step, the procedure is typically more complex and lacks the same lifespan as a successful first-time joint replacement. Accumulated trauma, scar tissue and mechanical breakdown of components lead to diminished performance. All to say, revision surgery may be required for function, but is not a guarantee of optimal results. No one should wish for a second knee, hip, or ankle surgery.
Exactech Hip Device Recall
In June 2021, Exactech issued an FDA Class II Medical Device Recall of its Exactech Connexion GXL acetabular polyethylene liners used in hip implants. Although the company referenced “risk of edge-loading and premature prosthesis wear” as a possibility in a certain sub-group of patients with specific implant configurations, studies have shown a broader link between catastrophic early polyethylene wear and the use of the Exactech Connexion GXL liner. These studies found the average length between initial implant and diagnosed hip implant failure to be five years or less.
Exactech Knee and Ankle Recall
In February, 2022, Exactech broadened the recall to several of its knee and ankle systems, again due to concerns that the polyethylene liners lead to accelerated excessive wear, bone loss, and device failure requiring revision surgery. The recalled knee and ankle systems include Optetrak (knee), Optetrak Logic (knee), Truliant (knee), and Vantage (ankle). As with the Exactech Connexion GXL hip liners, the tibial inserts/liners used in these knee and ankle implant systems are exhibiting early polyethylene wear, causing the devices to fail.
What Should I Do if I have an Exactech Implant?
You should have received a formal notice from your orthopedic surgeon or clinic if your surgery involved an Exactech device included in the recall. However, with a recall covering procedures from 2004-2022, don’t rely on the notice alone to determine whether you may be impacted. Your best bet would be to reach out to your treating physician directly. (find out whether your surgeon uses Exactech devices)
Surgeons have been advised to discontinue using the Exactech knee and ankle replacement systems in all patients, and devices returned to the manufacturer. For those who already have one of the recalled systems implanted, the company is advising doctors to maintain a patient index and to closely monitor for signs of potential device failure.
How will you know if you have a problem? Symptoms of an Exactech replacement system failure include:
• Pain
• Stiffness
• Inability to bear weight on joint
• Instability in the knee or ankle
• Grinding noise in joint and/or swelling
If you are experiencing any of these issues, your surgeon will order X-rays to determine whether device insert decay is leading to failure.
If the patient is not experiencing pain, decreased mobility, or other adverse symptoms of implant failure, preemptive surgery to remove the device is not recommended.
Your surgeon will determine whether your failed joint requires surgical removal and replacement.
Exactech Implant Claims
You may be entitled to compensation if you had a recalled Exactech replacement system surgically implanted in your knee or ankle and the insert component of that system failed.
Manufacturers like Exactech have a legal obligation to ensure that their products are safe in their design, manufacture, and packing and that they do not cause harm. Exactech’s recall acknowledges that all knee and ankle replacement products made since 2004 were defective and subject to high failure rates.
Compensation for Need for Second Surgery
Patients who required corrective revision surgery because of a defective Exactech implant can file a claim against the manufacturer and seek compensation. Compensation from a successful claim could include monetary damages for pain and suffering as well as medical expenses incurred out of pocket for surgery or related medical treatment. Damages for lost income may also be awarded.
With the 18-year span of the components recall, it is still best you speak with your treating orthopedic regarding any potential impact on your health
For more information related to this post, please contact Boteler Richardson Wolfe at 251.433.7766 or email us at knox@brwlawyers.com
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