Exactech Knee and Ankle Recall Lawsuit

Joint replacement surgery offers hope and independence to millions of patients who would otherwise live with chronic pain and mobility deficits. Knee replacement surgery is considered one of the most successful procedures medicine has offered, with a success rate of over 90% after 15 years. Ankle replacement surgery is also very effective in most cases.

Defective knee and ankle replacements compromise the success of these procedures and can cause serious complications. If you have undergone knee or ankle replacement in which Exactech components were used, you could be impacted by the recent recall. The attorneys at Levin & Perconti have over 200 years of combined experience helping victims of defective medical devices restore their lives and get justice.

Exactech has voluntarily recalled polyethylene inserts manufactured since 2004, which were used in partial knee replacements, total knee replacements, and ankle replacements. The affected products were marketed and sold under the following brand names:

• Optetrak
• Truliant
• Vantage

The recall was initiated on August 31, 2021, and updated in 2022 after Exactech discovered that 80% of their polyethylene (plastic) inserts were improperly packaged in bags that may not have adequately prevented oxygen permeation.

The bags used were oxygen-resistant vacuum bags, but they lacked the required secondary protective mechanism, a barrier layer that contains ethylene-vinyl alcohol.

Oxygen exposure can cause plastic products to break down prematurely through a process known as oxidation. Affected polyethylene inserts can wear out prematurely and lead to complications with the implants.

Worn polyethylene releases small particles into the bones and surrounding tissues in the vicinity of the knee or ankle replacement device. This results in inflammation that can ultimately lead to osteolysis, the progressive destruction of bone tissue. This results in softer, weaker, and sometimes smaller bones. The result is the loosening of the knee or ankle replacement.

Osteolysis itself does cause noticeable symptoms. Symptoms may not appear until after the bone is severely damaged and the joint replacement is loose. The resulting symptoms include the following:

• Persistent pain
• Swelling
• Decrease in joint function and stability
• Infection
• Generalized pain
• Grinding sounds or other noises
• Inability to bear weight

Exactech has provided documentation for physicians to provide to patients who have received the defective inserts. If your physician has not contacted you, it is important to reach out to your physician and inquire.

Your physician can determine whether you received a recalled insert and provide you with the brand name and serial number of your hip or knee replacement device. Exactech has provided a search feature on their website where you can search your device to determine if it is included in the recall by entering its serial number.

Exactech is not recommending preemptive surgery, but you will need to monitor the bone replacement for early signs of wear. Your physician can perform X-rays and diagnostic tests to ensure osteolysis is not taking place. If such signs exist, surgery may be necessary to prevent severe bone loss or infection. This is known as revision surgery.

Revision surgery is often more complicated than the original replacement surgery because the replacement may have fused to the bone or been cemented to the bone during the original replacement. Removing cement is a lengthy process, and additional procedures may be needed, such as the removal of damaged bone tissue and bone grafts.

The recovery process after revision surgery is similar to replacement surgery, except it may be longer. Recovery time can be shortened if the doctor is able to perform an isolated polyethylene exchange. This is not an option for all patients. Your physician can help you determine which procedure is most compatible with your circumstances.

Exactech is offering reimbursements for out-of-pocket expenses related to the recall. They have hired a Third Party Administrator, Broadspire, to manage claims. While this gesture by Exactech may seem helpful, the reimbursement program will likely fall short of compensating victims for the full extent of their losses.

Many knee and ankle replacement patients are elderly. Health factors common to the elderly could preclude revision surgery. These patients may be forced to live with chronic pain and reduced mobility, the very conditions they sought to ameliorate with the original replacement.

Some patients may opt for the surgery despite the health risks. This could result in premature death or other severe complications.

In destroying bone tissue, osteolysis presents the following additional risks:

• Fractures of the affected bones
• Falls leading to additional injuries, such as brain injuries and additional broken bones
• Decreased mobility, which jeopardizes the patient’s independence
• Depression and isolation

Recovery from revision arthroplasty is a slow, painful process that patients are forced to endure unnecessarily when defective medical devices cause harm. For those patients unable to undergo revision surgery, quality of life is drastically reduced.

Successful joint replacements offer independence and freedom from pain. When these benefits are lost due to the negligence of a manufacturer, patients lose hope. Health consequently deteriorates. The worsened health and reduced independence add financial pressure as health care and personal care needs increase.

When you received your knee or ankle replacement, you trusted the manufacturer to provide a safe and effective product. Medical device manufacturers’ duty of care includes the implementation of quality control measures that prevent defective products from reaching the market.

Exactech marketed and sold improperly packaged polyethylene inserts to the public for 17 years before the issue was detected. The company estimates that 143,484 inserts have been implanted during that time.

If you have been harmed by these devices, you may be entitled to the following compensation:

• Medical expenses
• Pain and suffering
• Costs associated with ongoing care
• Loss of society
• Loss of capacity to enjoy life
• Wrongful death compensation

If you or your loved one has been injured by Exactech’s defective polyethylene inserts, our product liability attorneys can ensure you receive fair compensation. Manufacturers hire expensive legal teams to represent their company’s best interests. They cannot be trusted to offer you a fair and reasonable settlement.

The experienced Chicago personal injury lawyers at Levin & Perconti have a long, successful track record of standing up to large companies like Exactech. We can help you calculate the true costs of your losses and ensure you receive compensation that meets your needs and provides justice for the harm you have suffered.

We are nationally recognized lawyers who have earned such distinguished recognition as Super Lawyers and Fellows of the Litigation Counsel of America. We were honored because of our long history of refusing to settle for anything less than the full compensation our clients deserve. We offer an initial no-obligation free consultation, and we never charge a fee until we win. Call us today at 312-900-8992 or contact us via our online contact form to schedule your free case evaluation.