The Exactech Equinoxe Shoulder System was designed to offer patients improved joint stability and range of motion. This system has gained popularity in the orthopedic community.
However, in August 2021, the FDA issued a warning about the shoulder system. The reason cited was a critical defect in the packaging, which potentially compromised the sterility and integrity of the device. This recall has had far-reaching implications for patients, healthcare professionals, and the medical device industry. This article provides an in-depth analysis of the recall, detailing the nature of the defect, the regulatory responses it prompted, and the subsequent legal ramifications for those affected.
If this recall has impacted you, it’s crucial to understand your rights and options. Nigh Goldenberg Raso & Vaughn law firm stands ready to assist. Our experienced legal team specializes in handling complex medical device lawsuits and is committed to ensuring you receive the compensation and justice you deserve.
Overview of the Recall
The Exactech Equinoxe Shoulder System Recall was initiated due to the discovery that implants made prior to August 2021 were packaged in defective materials. This defect could potentially lead to early failure, pain, bone loss, and other complications that may necessitate revision surgery.
Following the recall, numerous lawsuits have been filed against the company. These legal actions are primarily from individuals who have sustained injuries or experienced other health complications due to the defective Exactech Equinoxe Shoulder System.
In many instances, patients were not adequately informed about the recall, leading to confusion and further complications. As a result, many patients have sought legal help to address these issues.
Company Background
Legal Proceedings Against Exactech
The legal landscape surrounding Exactech has become increasingly complex due to multiple lawsuits. In 2021 Exactech recalled several products including Exactech knees, Exactech hips, and Exactech ankles for similar packaging problems. As a result two different coordinated actions were filed against Exactech. The first was in Alachua county where hundreds alleged the defective knee, hip, and ankle implants caused them severe pain and ultimate revision surgery. Another consolidated lawsuit was filed in the Eastern District of New York.
These lawsuits stem from issues related to the company’s joint replacement devices, including the Equinoxe Shoulder System, with claims focusing on premature failures and the need for revision surgeries due to defective packaging. Additionally, there are over 1,090 pending lawsuits consolidated in the Multidistrict Litigation (MDL) before the U.S. District Court, Eastern District of New York. Exactech faces a lawsuit under the False Claims Act, alleging fraud in selling defective knee replacement implants to Medicare, Medicaid, and VA, with the claim that the government would not have made payments had it known about the high failure rates of these implants.
The MDL is currently in the initial stages, with the number of cases steadily increasing. These legal proceedings are part of a broader narrative highlighting concerns about patient safety and device efficacy within the medical device industry. The lawsuits primarily involve product liability claims, with patients seeking compensation for injuries related to the premature failure of joint replacement devices, which include knee, hip, and ankle implants. These product issues are linked to defective packaging that led to early degradation of the devices, necessitating additional surgeries and causing significant pain and mobility issues for the patients.
Detailed Description of the Recalled Device
The Exactech Equinoxe Shoulder System is a joint replacement device designed for adults suffering from painful shoulder joints due to conditions like osteoarthritis, osteonecrosis, and rheumatoid arthritis.
The system consists of several components, each playing a crucial role in ensuring the proper functioning of the replaced joint. These components include:
- Glenoid Component: This is the part of the implant that replaces the socket in the shoulder blade.
- Humeral Component: This replaces the ball at the top of the upper arm bone.
Nature of the Defect
According to the FDA, the defect in the Exactech Equinoxe Shoulder System lies in the packaging. The packaging bags used were missing an oxygen barrier layer, which is vital in preventing oxidation. This oxidation can degrade the plastic components of the implant over time, leading to faster device wear or failure.
The FDA states that if a large amount of oxygen contacts the plastic component before the Equinoxe Shoulder System is implanted, it may lead to chemical change of the plastic component (oxidation). 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, and/or
- Ultimately, a revision surgery as a result of the above listed issues
Regulatory Response
FDA Safety Warning
In January 2024, the Food and Drug Administration (FDA) issued a Safety Communication to alert the public about the risks associated with the Exactech Equinoxe Shoulder System due to defective packaging.
The FDA warned that the defective packaging could lead to oxidation, which in turn could cause the implant to wear out or fail faster, device component cracking, or fractures. This could necessitate additional surgery to replace or correct the implanted device.
Legal Assistance and Compensation
Individuals who have been injured or have experienced health complications due to the Exactech Equinoxe Shoulder System are advised to seek legal counsel. A qualified attorney can help navigate the complexities of filing a lawsuit and seeking compensation for damages.
The potential for compensation is significant for those affected by the Exactech Shoulder Lawsuit. Compensation could cover medical expenses, pain and suffering, lost wages, and other damages.
Individuals affected by the Exactech Equinoxe Shoulder System Recall Lawsuit can seek legal help. If you have experienced any of the above-mentioned injuries, you may qualify for a claim. Our team at Nigh Goldenberg Raso & Vaughn can help navigate you through this process.
Frequently Asked Questions:
What are the issues with the Exactech Equinoxe Shoulder System?
The Exactech Equinoxe Shoulder System has been linked to various health issues and defects, leading to patient complications and the need for additional surgeries. The FDA warned that the defective packaging could lead to oxidation, which in turn could cause the implant to wear out or fail faster, device component cracking, or fractures.
Has there been a recall of the Exactech Equinoxe Shoulder System?
The FDA has issued a warning about Exactech Equinoxe shoulder systems manufactured before August 2021, advising against their use due to defective packaging.
Are there any lawsuits related to the Exactech Equinoxe Shoulder System?
Patients and families have filed lawsuits against Exactech due to complications from the defective Equinoxe Shoulder System. The lawsuits seek financial compensation for the pain, suffering, and additional medical expenses caused by the device’s defects.
How can I find out if I have a claim against Exactech?
If you have experienced complications or additional surgeries due to the Exactech Equinoxe Shoulder System, you may be eligible to file a claim. It is recommended to speak with a lawyer to understand your legal rights and options.
