Because prosthesis implants can be exceptionally adept in helping people regain their mobility without pain and discomfort, thousands of patients have been implanted with replacement systems. However, hip, knee, and ankle implants have an established history of severe issues and defects.
Reasons for Recall
Patients with this liner implanted during a revision or primary hip replacement surgery could need additional procedures to repair damage caused by the medical device. However, it was not until 2022 that most consumers learned of the design issues when the FDA expanded recalls for the potentially dangerous product, which affected nearly 150,000 patients. After receiving numerous reports of adverse effects associated with the defective systems, the FDA issued a Class II recall, which is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.”
After extensively testing the clinical performance of the Exactech polyethylene inserts, results confirmed that most of their total knee replacements and total ankle replacements with polyethylene components and inserts manufactured after 2004 were packaged in defective vacuum bags. These defects could have exposed products in this packaging to oxygen, which significantly degrades the liner, causing:
- Fractures
- Cracks
- Other adverse effects occur earlier than expected, sometimes as early as one-year post-implantation
GXL hip liners also pose a risk for premature wear. Exactech informed surgeons that patients with hip replacements that use the GXL liner could risk higher wear rates under certain conditions. This warning came after the company observed that 0.118% of patients who had implants for 3 to 6 years after initial surgery might have earlier wear on the liners.
Exactech listed contributing factors to premature GXL liner wear, including:
- Larger femoral heads
- Higher patient activity levels
- Devices that were implanted by using a direct anterior hip surgery approach
