01/19/2024
This week, the U.S. Food and Drug Administration (FDA) issued a safety notice cautioning both patients and healthcare providers about potential risks associated with specific shoulder joint replacement implants. This warning pertains to the Exactech Equinoxe Shoulder System and highlighting alarms over the packaging of this system, indicating that defects may lead to significant health risks for patients.
Understanding the FDA Warning
In its warning, the FDA cautions that Equinoxe shoulder System devices distributed from 2004 and August 2021 were packaged in defective bags that lacked a one of the oxygen barrier layers. This layer is intended to protect the devices from oxidation, a chemical reaction with oxygen that can degrade plastic components over time. Oxidation can lead to faster device wear or failure, and device component cracking or fracture.
As of now, Exactech has chosen not to instigate a voluntary recall concerning this matter. The FDA says it plans to continue working with the company to evaluate the risks related to the warning.
What are Equinoxe Shoulder System?
The Equinoxe Shoulder System, which is sold by Exactech, is a medical device used in adults to replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue present. The implants have been sold in the U.S. since 2004.
Potential Health Risks
Oxidation of the plastic component over time can result in the risk of:
- Early and excessive device wear
- Component fracture
- Device failure
- New or worsening pain
- Bone loss
- Swelling in the affected area
This could lead people with the device to need additional surgery to replace or correct the implanted Equinoxe Shoulder System.
Due to these identified risks, the FDA recommends that healthcare providers refrain from implanting any Equinoxe systems that were packaged in the faulty bags. Additionally, providers should closely monitor patients who have already received implants between 2004 and 2021. While the FDA does not advise the preemptive removal or replacement of currently well-functioning systems, it suggests that doctors consider revision surgery for patients experiencing escalating pain or joint weakness associated with the implant.
Legal Implications
If you or a loved one has experienced adverse effects or complications due to the Exactech Equinoxe Shoulder System, you may be entitled to legal recourse. Manufacturers have a duty to ensure the safety of their products, and when they fall short, legal action becomes a crucial avenue for seeking justice.
Steps to Take if Affected:
- Seek Medical Attention: If you are experiencing any symptoms or complications associated with the Exactech Equinoxe Shoulder System, it is imperative to seek immediate medical attention.
- Document Everything: Keep detailed records of your medical treatments, symptoms, and any communication with healthcare professionals regarding the issues you are facing.
- Consult Legal Professionals: Reach out to a personal injury lawyer with experience in defective product cases. They can evaluate your situation, provide guidance on your legal options, and help you navigate the complexities of filing a claim.
Why Choose Meyers-Flowers for Your Defective Exactech Device?
As a top tier law firm, Meyers & Flowers has decades of experience pursuing large corporate medical device companies. Exactech has the responsibility of providing safe, reliable devices to the public and failing to do this bears the consequences. Unfortunately getting proper compensation from large corporations requires forceful application of the laws covering negligence and personal injury.
Our attorneys have obtained millions of dollars for our clients both in settlement negotiations and high dollar awards at trial. We have a formidable team of professionals who relentlessly prepare every case for trial, showing the opposition that we are prepared and will succeed before a jury. Our expertise in successfully prosecuting those responsible for releasing defective medical devices and harmful drugs is well known; we are fully able to litigate a successful lawsuit throughout the United States.
Contact us today for a free case evaluation online or by phone at (630) 576-9696. No fee unless we win or settle your case.