Exactech Equinoxe Shoulder Systems made before August 2021 had defective packaging that could lead to pain, early failure, bone loss, and other problems that may require revision surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Exactech shoulder implant induced injury cases in all 50 states. If you or somebody you know was injured by an Exactech Equinoxe Shoulder Replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
FDA Safety Warning for Exactech Shoulder Implants
In January 2024, the FDA issued a Safety Communication to warn about risks with Exactech Equinoxe Shoulder Systems with defective packaging.
What is the Equinoxe Shoulder System?
Exactech manufactures the Equinoxe Shoulder System, a joint replacement device for adults with painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or loss of normal structure and function.
What is the Problem?
The Equinoxe Shoulder System was manufactured by Exactech between 2004 and August 2021 and packaged in defective bags.
The defective bags used to package the Equinoxe Shoulder System were missing one of the oxygen barrier layers that protect the devices from oxidization before they are implanted into a person’s body.
What is Oxidization?
Oxidization is a chemical reaction in which oxygen degrades the plastic components in the shoulder implant. Oxidization can lead to the implant wearing out or failing faster, device component cracking, or fractures. As a result, people with this implant may need additional surgery to replace or fix the implanted Equinoxe Shoulder System.
Signs & Symptoms of Equinoxe Shoulder System Failure
- New or worsening pain
- New or worsening swelling
- Inability to use your arm
- Grinding or other noise
- Weakness around the shoulder implant
- Shoulder implant wearing out early or failing
- Bone loss
- Joint weakness
- Device failure
- Revision surgery as a result of these issues
What Should I Do?
The FDA is warning doctors not to implant any Exactech Equinoxe Shoulder System implants that were packaged in defective bags, or manufactured between 2004 and August 2021.
Patients who were already implanted with these devices should be monitored for “device wear, failure, or bone loss. Consider performing X-rays to further evaluate the patient and their implanted device if you suspect a failed device,” according to the FDA.
Patients may need revision surgery if they are suffering from new or worsening pain, joint weakness, or other symptoms of their joint implant failing and breaking prematurely.
Exactech Facing 1,500 Lawsuits for Defective Joint Implants
Exactech is already facing more than 1,500 lawsuits involving knee implants, hip implants, and ankle implants that were packaged in “out-of-specification” bags.
These bags failed to prevent oxygen from damaging the plastic components of the devices before they were implanted, which caused many of the implants to crack, break, or fail prematurely.
The lawsuits involve people who suffered pain, joint problems, or needed revision surgery to remove and replace their defective joint implants. Exactech is accused of failing to immediately pull these implants off the market as soon as the company knew about excessively high failure rates. Exactech did not start warning doctors about the risk of high failure rates with their implants until June 2021.
Do I have an Exactech Shoulder Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting Exactech shoulder implant induced injury cases in all 50 states. If you or somebody you know was injured by an Exactech Equinoxe Shoulder Replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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