Exactech, a prominent medical device manufacturer, has initiated recalls pertaining to polyethylene liners in knee and ankle implants produced from 2004 onwards due to packaging issues. These defects may lead to premature degradation of the liners, potentially resulting in serious complications such as bone loss, necessitating revision surgery. A substantial number of these recalled inserts, totaling 147,732, were implanted by surgeons across the United States.
Key Points:
- Recall Initiation and Expansion: The recall of polyethylene liners for specific knee and ankle implants commenced in August 2021, with subsequent expansion in February 2022. Defective packaging allowing oxygen entry prompted this recall, potentially causing early liner degradation.
- Legal Consolidation: The Judicial Panel on Multidistrict Litigation consolidated at least 75 lawsuits against Exactech in October 2022, reflecting the magnitude of the issue. Since August 2021, approximately 200,000 knee, hip, and ankle prosthetics have been recalled.
- Communication Regarding Hip Replacement Liners: In June 2021, Exactech communicated to physicians regarding the phase-out of polyethylene Exactech GXL Connexion liners utilized in hip replacement products like Novation, Acumatch, and MCS systems. While not classified as a recall, Exactech planned to transition to its new XLE polyethylene liner infused with Vitamin E.
- FDA Alert: In March 2023, the FDA reiterated concerns regarding defective packaging in Exactech’s knee, hip, and ankle replacements, emphasizing heightened risks of revision surgeries and bone loss due to excessive device wear or failure.
Recalled Knee and Ankle Replacements:
- The recall encompasses all Optetrak, Truliant, and Vantage brand knee and ankle replacement liners manufactured from 2004 onwards. Exactech advises against implanting nonconforming products and urges the return of both conforming and nonconforming devices.
- Specific components affected include Optetrak All-Polyethylene CR Tibial Components, Truliant CR Slope Tibial Inserts, and Vantage Fixed-Bearing Liner Component GXL Hip Liners.
Premature Wear Risks in Connexion GXL Hip Liners:
- While no formal recall has been issued for Connexion GXL hip replacements, Exactech alerted surgeons to potential elevated wear rates in patients with implants utilizing the GXL liner under certain conditions. The company observed premature wear in a small percentage of patients, prompting plans to phase out GXL liners from the U.S. market.
Previous Issues and Legal Proceedings:
- Prior to recent recalls, Exactech faced challenges with its joint replacements, particularly the Optetrak Knee System, which exhibited higher revision rates compared to alternative devices. A whistleblower lawsuit accused the company of knowingly distributing faulty knee replacement devices to Medicare, Medicaid, and Department of Veterans Affairs beneficiaries.
Reasons for the Exactech Replacements Recall:
- Defective packaging allowing oxygen ingress was identified in most knee and ankle replacements manufactured since 2004, resulting in severe liner degradation. The FDA classified the recall as Class II, indicating potential temporary or reversible health consequences, with risks including early failure, bone loss, and component fracture necessitating revision surgery.
Recommended Actions and Monitoring:
- Surgeons may reach out to patients for follow-up appointments if their implants are on the recall list. Patients are advised to monitor for symptoms related to polyethylene wear and consult a doctor if symptoms such as joint clicking, instability, or pain while walking arise.
- Individuals affected by the recall should schedule appointments with their surgeons, and those experiencing symptoms may consider revision surgery. Doctors are advised to closely monitor patients with recalled inserts for potential osteolysis and excessive wear.
This comprehensive update underscores the importance of addressing safety concerns associated with Exactech hip, knee, and ankle replacements and emphasizes the need for proactive patient monitoring and communication.
