Dive Brief:
- The U.S. Food and Drug Administration (FDA) has told healthcare professionals not to implant any of Exactech’s recalled knee, ankle and hip devices.
- Exactech began recalling hip replacement devices due to excessive wear in 2021. The next year, the company began recalling knee and total ankle replacements that were packaged in defective bags.
- The FDA issued a notice in September when it classified the expanded hip recall as a Class II event, and reminded patients and healthcare professionals of the problem on Thursday.
Dive Insight:
When Exactech began the first recall in June 2021, it was unsure why some hip replacement devices were wearing out prematurely. The next year, the manufacturer of orthopedic implants identified defective packaging bags that lacked an oxygen barrier layer as the cause of the problem. In functioning bags, the layer protects the device from oxidation that can degrade plastics.
All Exactech joint replacement devices contain a plastic component which should be in packaging that contains multiple oxygen barrier layers, the FDA said. When a layer is missing, oxidation of Exactech implants can accelerate the wear or failure of the devices and cause components to crack or fracture. In doing so, oxidation can increase the risk of revision surgeries and bone loss related to device failure.
The recall covers devices made between 2004 and August 2021. Exactech found around 80% of the knee and ankle replacement devices it made over the period were packaged in defective bags, suggesting most recipients of the implants received products that may have been at risk of oxidation.
Based on the current evidence, the FDA is recommending against removing “well-functioning Exactech joint replacement devices from patients who do not have any new or worsening pain or symptoms.” The agency is advising healthcare professionals to monitor people who received recalled devices, potentially by X-raying the patient if they suspect a failed device. No recalled devices should be newly implanted.
