Texas Exactech Equinoxe Shoulder Lawyer

The FDA is warning patients that certain Exactech Equinoxe Shoulder Implants can fail prematurely and cause pain, bone loss, or other problems that need surgery.

Need a Texas Exactech Equinoxe Shoulder Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were injured or needed surgery for an Exactech Equinoxe Shoulder Implant that failed prematurely, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

FDA Safety Warning for Exactech Equinoxe Shoulder Implants

In January 2024, the FDA published a Safety Communication because the Exactech Equinoxe Shoulder System has defective packaging that could cause it to fail prematurely, resulting in severe pain, bone loss, and other complications that require revision surgery.

What is the Exactech Equinoxe?

The Equinoxe Shoulder System is a joint replacement device that is made by Exactech. It is designed for adults with painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and other problems that cause a loss of normal shoulder structure or function.

What is the Problem?

According to the FDA, Exactech used defective bags to package the Equinoxe Shoulder System between 2004 and August 2021.

Devices that were manufactured during this time were packaged in “out-of-specification” bags, which were missing one of the oxygen barrier layers. As a result, oxygen can come in contact with the plastic components of the Equinoxe Shoulder System before it is implanted.

This is a problem because oxygen can degrade some of the plastic components, causing the plastic components of the Equinoxe shoulder implant to wear out faster than usual, fail, crack, or break, resulting in severe pain and other problems that require surgery.

Oxidization is a chemical reaction that occurs when oxygen in the air comes in contact with plastic components in the Equinoxe Shoulder System. Patients who were implanted with this device may be at a higher risk of problems that require revision surgery within 5 years.

Warning Signs of Exactech Shoulder Implants Failing

• Shoulder pain that is new or worsening
• Swelling that is new or worsening
• Unable to use the arm
• Grinding or other unusual noise in the joint
• Weakness around the implant
• Bone loss
• Joint weakness or instability
• Device failure, cracking, or breaking
• Needing revision surgery as a result of these issues

FDA Recommendation for Patients

The FDA is warning orthopedic surgeons not to implant any Exactech Equinoxe Shoulder Systems that were packaged in defective bags between 2004 and August 2021.

For patients who have already been implanted with these shoulder replacements, the FDA is not recommending routine revision surgery.

Instead, patients who received these devices will need routine check-ups to monitor 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 having problems with their shoulder implant, such as new or worsening pain, joint weakness, or other symptoms of their joint implant breaking or failing.

Over 1,500 Joint Implant Lawsuits Filed Against Exactech

Exactech has been hit by over 1,500 lawsuits involving knee implants, hip implants, and ankle implants that were packaged in defective bags, making them prone to oxidization and premature failure. Many lawsuits were filed by people who suffered excruciating pain and needed revision surgery within 5 years of receiving the implant.

Most of these lawsuits have been centralized in a federal Multi-District Litigation (MDL): IN RE: Exactech Polyethylene Orthopedic Products Liability Litigation, MDL No. 3044.

The lawsuits accuse Exactech of failing to immediately recall all of these joint implants as soon as they knew about high failure rates. In fact, Exactech did not start warning orthopedic surgeons about the high risk of failure until June 2021, after most of the devices in defective bags had already been implanted in patients.

Need an Exactech Equinoxe Shoulder Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.