Exactech Shoulder Replacement Concerns: What You Need to Know

The Exactech Equinoxe Shoulder System, a widely used joint replacement device, has come under scrutiny due to defective packaging, which has led to concerns about the potential for device oxidation and premature failure. This issue is critical for patients and healthcare providers alike, as it could impact the longevity and safety of the implants.

The Issue at Hand

The U.S. Food and Drug Administration (FDA) has issued warnings regarding the Exactech Equinoxe Shoulder System, which was sold between 2004 and August 2021. The problem lies in the packaging of these devices; specifically, the omission of an oxygen barrier layer essential for preventing oxidation—a chemical reaction that can degrade the plastic components of the implants over time. This degradation can lead to device wear, cracks, or even fractures, which might necessitate additional surgeries to repair or replace the implant​.

FDA’s Response and Recommendations

The  FDA has issued a safety communication regarding the risks of the Exactech shoulder system. Exactech has since voluntarily recalled the product. For patients with implants already in place, the FDA advises monitoring for any signs of failure. This includes new or worsening pain, swelling, difficulty using the arm, or unusual noises from the joint.

How Can A Personal Injury Law Firm Help?

Patients who have suffered due to these defective devices may have grounds for claims against Exactech, particularly if they face unexpected surgeries or other medical interventions due to implant failure. KBA can help navigate the complexities of medical product litigation and work to secure compensation for medical costs, pain and suffering, and other damages.  If you have been injured by a recalled Exactech Shoulder Replacement, contact the attorneys at  KBA to see what we can do to help.