Rheingold Giuffra Ruffo Plotkin & Hellman LLP is actively pursuing legal action on behalf of individuals affected by defective Exactech Equinoxe Shoulder system replacements manufactured between 2004 and August 2021.

The Equinoxe Shoulder System serves as a medical option for adults experiencing painful shoulder joints due to conditions such as osteoarthritis, osteonecrosis, rheumatoid arthritis, or structural and functional issues. Moreover, these devices can potentially improve previous unsuccessful shoulder joint replacements, provided there is adequate bone and soft tissue available.

Device Failure Associated with Exactech Equinoxe Shoulder Packaging

Prior to August 2021, Exactech employed hazardous and faulty packaging for these systems, leading to oxidation on the implants before reaching the patient. This corrosion poses a substantial threat as it can deteriorate the plastic components of the implants, complicating surgeries significantly. The repercussions include early and excessive device wear, component fracture, device failure, bone loss, swelling in the affected area, and often necessitate additional surgeries to remove and replace the failing implant.

As early as 2016, a study documented “implant-related inflammation” in the body associated with implants utilizing plastic (polyethylene) components.[i]

[i] Aryasit, O, Delayed onset porous polyethylene implant-related inflammation after orbital blowout fracture repair: four case reports. BMC Ophthalmol. 16: 94 (July 2016).

Developments from the FDA

On January 16, 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the Exactech Equinoxe Shoulder System, revealing that the devices were shipped in defective packaging lacking essential oxygen barrier layers.[i]

Despite this development, the company chose to disregard the FDA’s recommendation to recall their products. This refusal, coupled with the evident dangers posed by the replacements, provides compelling grounds for litigation.

How Our Attorneys Can Help

While no one can undo permanent damage done by an injury, a lawsuit can help the victim and their family recover losses and receive the medical treatment they deserve in the future. Our skilled New York attorneys are dedicated to investigating the cause of these injuries and doing whatever is necessary to make sure the offending products are kept away from innocent people.

If you are experiencing any of the following symptoms:

• Increasing swelling or pain
• Loss of arm mobility
• Audible grinding or other abnormal noises
• Weakness surrounding your implanted device

Or if you have encountered any complications related to an Exactech shoulder implant, don’t hesitate to contact Rheingold Giuffra Ruffo Plotkin & Hellman LLP today to explore your legal options.

[i] Division of Industry and Consumer Education, Risks with Exactech Equinoxe Shoulder System with Defective Packaging. FDA Safety Communication. (January 2024).