FDA safety alert targets shoulder implant packaging

Editor's Note:

Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and 2021 are at risk of premature wearing or failure due to defective packaging, according to a January 16 safety alert from the US Food and Drug Administration (FDA).

The bags used to package the devices were missing one of the oxygen barrier layers that prevents oxidation, which can degrade plastic components over time. Failure, cracking, or wear could result in patients requiring additional surgery to replace or correct the implanted system.

However, the safety alert does not recommend surgery to remove well-functioning devices. Rather, those with symptoms (such as worsening pain or swelling, inability to move the arm, weakness, or odd noises) should contact their healthcare providers. Other patients should be monitored carefully, and providers should not use any systems packaged in defective bags.

Equinoxe Shoulder System implants are medical devices used in adults to replace shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or loss of normal structure and function.  Although Exactech has declined to initiate a voluntary recall, FDA is reportedly working with the company and regulatory agencies to review data and determine causes. FDA also issued a similar alert about other Exactech joint replacement devices in March 2023.