Equinoxe devices replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue present.
Exactech manufactured these devices between 2004 and August 2021, packaging them in defective bags, the agency says. The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation. This chemical reaction can degrade plastic components over time.
Oxidation can lead to faster device wear or failure, plus device component cracking or fracture. This could in turn lead to additional surgeries to replace or correct the Equionoxe shoulder implant.
The FDA recommended that, if a patient has a functioning Equinoxe implant with no pain or symptoms, they don’t need surgery. Patients should contact healthcare providers if they experience worsening pain or swelling, inability to use their arm, grinding or other noises or weakness around the implanted device with Equinoxe.
Providers should not implant Equinoxe systems packaged in defective bags, the FDA said. They should monitor patients implanted with an Equinoxe system manufactured between 2004 and August 2021.
To date, Exactech has declined to initiate a voluntary recall for this issue. The FDA says it plans to continue working with the company to evaluate the risks related to the warning. According to the agency, it issued a safety communication 10 months ago to warn of a similar issue with other Exactech joint replacement devices.