Equinoxe Shoulder Systems Device Degradation / Malfunction Lawsuits

How To Obtain Full Compensation For Equinoxe Shoulder Systems Device Degradation or Malfunction Post-Implantation

The Equinoxe Shoulder System joint replacement devices, manufactured by Exactech between 2004 and August 2021, have been flagged by the FDA due to potential health hazards stemming from defective packaging. These devices, packaged in faulty bags lacking crucial oxygen barrier layers, pose significant risks such as accelerated device wear, fracture, failure, and associated complications like pain, bone loss, and swelling.

If you or a loved one has suffered Equinoxe Shoulder Systems device degradation or malfunction post-implantation, it’s crucial to understand how to obtain full compensation for your losses.

Parker Waichman LLP, a top-rated national product liability law firm has recovered over $2 billion in compensation for our clients who have been injured or lost loved ones due to defective products.

Parker Waichman LLP is offering free consultations and is currently representing claimants in Equinoxe Shoulder Systems lawsuits throughout the United States. These lawsuits seek to recover compensation for those harmed by device degradation or malfunction that has caused severe complications, including injuries, impairment, and corrective surgery. Contact us today at 1-800-YOURLAWYER (1-800-968-7529) to discuss your situation and learn more about how we can help you obtain the economic compensation your case deserves.

What Are Exactech Equinoxe Shoulder Systems?

The Equinoxe Shoulder System is a series of medical devices designed for shoulder joint replacement procedures, primarily aimed at alleviating pain and improving function in patients suffering from conditions such as osteoarthritis, osteonecrosis, rheumatoid arthritis, and structural deformities. Developed by Exactech, these systems have been utilized in adult patients experiencing significant shoulder joint deterioration or failure, either as a result of degenerative diseases or previous unsuccessful joint replacement surgeries.

The Equinoxe Shoulder Systems consist of various components, including humeral heads, glenoid components, stems, and other associated instruments, allowing orthopedic surgeons to tailor the implantation process according to each patient’s specific needs and anatomical characteristics.

These systems are engineered to mimic the natural movement and function of the shoulder joint, restoring mobility and enhancing overall quality of life for individuals suffering from debilitating shoulder conditions.

One of the key features of the Equinoxe Shoulder Systems is their versatility and adaptability to different patient anatomies and pathologies. With a range of sizes, configurations, and surgical techniques available, orthopedic surgeons can select the most appropriate components to optimize surgical outcomes and patient satisfaction. Additionally, the Equinoxe Shoulder Systems incorporate advanced materials and design principles to promote long-term durability and stability, essential factors in ensuring the success of shoulder replacement procedures.

The U.S. FDA Issues a Safety Communication

The U.S. Food and Drug Administration (FDA) issued a safety communication on January 16, 2024, regarding potential health risks associated with the Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and August 2021. These devices were packaged in defective bags, which could lead to oxidation of the plastic components over time, posing risks such as device wear, fracture, failure, pain, bone loss, swelling, and the need for revision surgery.

Patients with well-functioning Equinoxe Shoulder Systems and no symptoms are not recommended to undergo surgery. However, those experiencing pain, swelling, arm weakness, or unusual noises around the implanted device should contact their healthcare provider.

Health care providers are advised not to implant any Equinoxe Shoulder Systems packaged in defective bags and to monitor patients for potential device-related issues, considering X-rays if device failure is suspected.

Equinoxe Shoulder System implants are used in adults to replace painful shoulder joints due to various conditions, including osteoarthritis and rheumatoid arthritis. Defective packaging, missing an oxygen barrier layer, can allow oxygen to contact the plastic components before implantation, leading to oxidation and subsequent complications.

Patients experiencing problems with their devices are encouraged to report them through the FDA’s MedWatch Voluntary Reporting Form. The Unique Device Identifier (UDI) system helps identify individual medical devices, facilitating more accurate reporting and analysis of adverse events. An affected device can be identified by checking the UDI on its label.

Despite the FDA’s alert, Exactech has not initiated a voluntary recall for the affected implants. The FDA continues to collaborate with Exactech and international regulatory agencies to evaluate the safety and effectiveness of joint replacement devices containing plastic components packaged in defective bags. Updates will be provided as significant information becomes available.