Medical device maker Exactech has expanded a previous recall of its knee and ankle implants to include all total knee replacement (TKR) and total ankle replacement (TAR) systems with polyethylene components manufactured since 2004 that were packaged in “non-conforming” vacuum bags. According to the recall notification, the defective packaging is missing a secondary barrier layer containing ethylene vinyl alcohol (EVOH), which is meant to keep oxygen from diffusing into the implants while they are being stored, and causing the devices to wear prematurely or become damaged after implantation. If you or someone you love has suffered pain in a replaced knee or ankle joint, implant loosening or fracture, bone loss, instability, or the need for revision surgery to remove or replace a recalled Exactech knee or ankle implant, contact Consumer Safety Watch today to find out whether you may be eligible to file a claim against the manufacturer for compensation.
Individuals experiencing pain, weakness, or loss of mobility in the knee or ankle joint due to disease or injury may opt for joint replacement surgery, also known as arthroplasty, a procedure in which a damaged joint is replaced with an artificial joint, usually composed of metal, ceramic, plastic, or a combination of these materials. Exactech’s total knee replacement (TKR) and total ankle replacement (TAR) systems feature a plastic insert that fits between the implant components and acts as the new cushion or cartilage for the replaced knee or ankle joint. These knee and ankle systems are marketed to individuals experiencing pain, loss of mobility, muscle weakness and other issues as a result of disease, trauma, or other causes. However, this Exactech knee and ankle recall means that implant recipients may now be at risk for chronic pain, swelling, accelerated wear of the replaced joint, implant loosening or fracture, bone loss, joint instability, and other serious complications.
The problem with Exactech’s knee and ankle devices spans nearly 20 years and affects the manufacturer’s Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts. These polyethylene components were used in Exactech’s OPTETRAK, OPTETRAK Logic, TRULIANT, and VANTAGE total knee replacement and total ankle replacement systems implanted between 2004 and 2022. According to Exactech, most of the company’s plastic inserts manufactured since 2004 were improperly packaged in out-of-specification vacuum bags that are oxygen resistant but do not contain a secondary barrier layer designed to further augment oxygen resistance and prevent premature wear. Unfortunately, since 2004, more than 145,000 of these systems have been implanted in patients in the United States alone.
It was during a recent review of its implant manufacturing process that Exactech discovered that the secondary barrier layer of the packaging for its plastic knee and ankle inserts has been out of specification and may therefore allow oxygen to diffuse into the inserts prior to implantation. As a result, Exactech warned, the replaced joint may suffer mechanical failure or premature wear after being implanted, which could damage the joint or lead to bone loss and other complications that may require revision surgery. With an eye on this issue, Exactech announced a preliminary medical device recall on August 30, 2021, removing from the market all Knee and Ankle UHMWPE implants labeled with an eight-year shelf life and not packaged in EVOH/Nylon bags.
In a letter to Exactech surgeons issued on February 7, 2022, the manufacturer expanded the device recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life,” indicating that most of its polyethylene inserts manufactured since 2004 had been packaged in the out-of-specification vacuum bags. The company also indicated that between the initial device recall in August 2021 and January 2022, “non-conforming knee and ankle devices have been shipped and implanted by surgeons,” despite concerns that the implants may have been improperly packaged in non-conforming vacuum bags. As a result of this issue, patients suffering from arthritis or trauma who received an affected Exactech knee or ankle device expecting the implant to improve their mobility and quality of life may now be at risk for complications leading to the need for additional revision surgery.
Exactech claims on its website that its joint replacement systems “are clinically-proven and have performed well over time,” and that they feature “specially made plastic inserts designed to hold up well over time.” However, Exactech indicates in its February 2022 letter to surgeons that its recalled knee and ankle systems have shown statistically significant higher overall revision rates as compared to other replacement systems. If you or someone you know has received an Exactech knee or ankle implant affected by the recall, contact Consumer Safety Watch as soon as possible. You may qualify for compensation for your medical bills, pain and suffering, and other damages, which a knowledgeable Exactech recall attorney can help you pursue. With an experienced product liability lawyer on your side, you can significantly improve your chances of recovering the compensation you deserve for your injuries and losses.