FDA flags defective packaging of Exactech shoulder joint devices
The U.S. Food and Drug Administration (FDA) has issued a safety communication highlighting concerns that Equinoxe Shoulder System joint replacement devices have been shipped in defective packaging that could pose risks to patients.
Some of the bags used for shipping lacked a crucial oxygen barrier layer designed to shield the devices from oxidation. Oxidation is a chemical reaction that can cause plastic components to deteriorate over time. This deterioration may lead to accelerated device wear, device component cracks or even fractures, potentially requiring additional surgery.
The Equinoxe Shoulder Systems were produced by Exactech between 2004 and August 2021. The FDA previously issued a Safety Communication on March 23, 2023, regarding a similar issue with other Exactech joint replacement devices. Prior to that, in June 2021, Exactech recalled some GXL Liners for Novation, Acumatch, and MCS hip replacement devices due to excessive and premature wear. Exactech expanded the recall in August 2022 to include all hip devices with polyethylene components packaged in defective bags.
As of now, Exactech has not initiated a voluntary recall for Equinoxe Shoulder System implants. The FDA is actively working with Exactech to assess the risks associated with joint devices containing plastic components in defective packaging.
Healthcare providers should refrain from using Equinoxe Shoulder Systems packaged in defective bags, though removal of properly functioning devices is not advised, based on the available information. Providers are urged to monitor patients with the affected devices and if there are signs of a failed device, further evaluation through X-rays is recommended.
For patients who currently have a well-functioning Equinoxe Shoulder System and experience no pain or discomfort, the FDA does not recommend surgery for device removal. However, if you have this implant and notice new or worsening pain, swelling, difficulty using your arm, unusual noises or weakness around the implanted device, contact your healthcare provider promptly.
Evan joined TriMed in 2011, writing primarily for Health Imaging. Prior to diving into medical journalism, Evan worked for the Nine Network of Public Media in St. Louis. He also has worked in public relations and education. Evan studied journalism at the University of Missouri, with an emphasis on broadcast media.