FDA Safety Communication - Exactech Equinoxe Shoulder System

FDA Safety Communication  

April 19 Update: 

Exactech has initiated a recall to remove Equinoxe Shoulder System devices packaged in the defective bags from facilities’ unused inventory. To see if your device is affected by the recall, visit Exactech’s Recall Information Page. 

Original FDA Safety Communication – Exactech Equinoxe Shoulder System Packaging Defect 

The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding potential risks associated with the Equinoxe Shoulder System joint replacement devices manufactured by Exactech.  

The devices, produced between 2004 and August 2021, were packaged in defective bags lacking an essential oxygen barrier layer that would protect the products from oxidation. Oxidation can lead to accelerated device wear, component cracking or fracture, and ultimately, device failure. 

Patient Recommendations 

If your Equinoxe Shoulder System is functioning well with no pain or symptoms, surgery is not recommended. 

Contact your healthcare provider if you experience new or worsening pain, swelling, inability to use your arm, or weakness around the implanted device. 

Healthcare Provider Recommendations 

• Avoid implanting Equinoxe Shoulder Systems packaged in defective bags. 
• Monitor patients with these devices for signs of wear, failure, or bone loss. 
• Consider X-rays for further evaluation if device failure is suspected. 
• Discuss revision surgery with patients experiencing worsening pain or weakness attributable to the device. 

Device Description

The Equinoxe Shoulder System implants are advanced medical devices designed to address debilitating shoulder conditions in adults. Primarily, they serve to alleviate pain and restore function in individuals suffering from osteoarthritis, osteonecrosis, rheumatoid arthritis, or structural deterioration of the shoulder joint. 

The implants are versatile, to not only address primary shoulder conditions but also provide a solution for cases where previous shoulder joint replacement surgeries have failed. This versatility extends to situations where there is sufficient bone and soft tissue remaining, allowing for the improvement of failed shoulder implants through the Equinoxe Shoulder System. 

In essence, these implants offer a comprehensive solution to a range of shoulder ailments, aiming to enhance patients’ quality of life by reducing pain, restoring mobility, and improving overall shoulder function. 

Reporting Problems 

Patients are encouraged to report device problems through the MedWatch Voluntary Reporting Form or by calling 1-800-332-1088. https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting 

Unique Device Identifier (UDI) 

The unique device identifier (UDI) is a code that is part of a crucial system implemented to distinguish individual medical devices throughout their lifecycle – from production to distribution and ultimately to patient use.  

By assigning a unique numeric or alphanumeric code to each device, the UDI facilitates accurate tracking and documentation, enhancing transparency and accountability in the healthcare system. 

UDIs play a vital role in improving patient safety by enabling more precise reporting, review, and analysis of adverse events associated with medical devices. They allow any issues or concerns related to a specific device to be identified promptly, allowing for timely intervention and resolution to mitigate potential risks. 

In the case of the Equinoxe shoulder devices affected by the packaging defect, UDIs serve as a key tool for identifying the impacted products. By referencing the UDI table provided in the FDA Safety Communication stakeholders can locate the specific devices packaged in the defective bags.  

FDA Actions 

As of January 2024, Exactech had not initiated a voluntary recall for the affected devices. The FDA is collaborating with international regulatory agencies to assess data and explore causes of higher failure rates. 

Questions 

For inquiries, contact the FDA’s Division of Industry and Consumer Education at DICE@fda.hhs.gov or call 800-638-2041 or 301-796-7100. 

Stay informed as the FDA continues to provide updates on this matter. Your health and safety are paramount. 

Links

Read the Exactech recall notice here.

Read the FDA Safety Communication here.