Exactech Equinoxe Shoulder Replacement Problems May Be Caused By Defective Packaging: FDA

The FDA is warning doctors not to implant Exactech Equinoxe shoulder systems manufactured before August 2021, due to defective packaging that could increase the risk of early problems with the shoulder replacement.

Federal regulators indicate that the same manufacturing problems that led to a massive Exactech recall for knee implants, hip implants and ankle implants in 2022, may also plague Equinoxe shoulder systems sold by the company. However, Exactech is refusing to pull the potentially defective should replacements from the market.

The U.S. Food and Drug Administration (FDA) issued an Exactech Equinoxe Shoulder System safety communication on January 16, indicating the devices were shipped in defective packaging that may allow oxygen to reach the components, causing oxidation before the should replacement is implanted in patients.

The agency warns these Equinoxe shoulder replacement problems may increase the risk of failure, resulting in the need for additional surgery or revision surgery to remove and replace the failing implant.

Prior Exactech Recalls Over Defective Packaging

Problems with defective “out-of-specification” packaging previously led to an Exactech joint replacement recall in February 2022, impacting more than than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems implanted in patients since 2004, as well as 1,500 components used in Exactech Vantage ankle replacements.

Similar packaging problems have also impacted Exactech Novation and Acumatch hip implants since 2008, which were recalled in June 2021, and the Exactech hip recall was expanded in August 2022, to add another 40,000 joint replacements that may fail prematurely.

As a result, more than 1,500 Exactech knee implant lawsuits, hip implant lawsuits and ankle lawsuits have been filed against the manufacturer, each raising similar claims that patients experienced problems when the components degraded and failed, after oxygen was allowed to reach the components before they were implanted.

Equinoxe Should Replacement Defective Packaging

Exactech Equinoxe shoulder systems manufactured between 2004 and August 2021 also appear to be impacted by similar packaging problems, the FDA now warns. However, the FDA notes that Exactech has so far refused to issue a voluntary Equinoxe shoulder replacement recall for the potentially defective implants.

“The defective bags used to package the Equinoxe Shoulder System devices were missing one of the oxygen barrier layers that protect the devices from oxidation, a chemical reaction with oxygen that can degrade plastic components over time,” the agency’s safety communication states. “Oxidation can lead to faster device wear or failure, and device component cracking or fracture. This could lead people with the device to need additional surgery to replace or correct the implanted Equinoxe Shoulder System.”

The FDA warns that the bags increase the risk of early and excessive wear, component fracture, device failure, new or worsening pain, bone loss, swelling or the need for revision surgery.

The agency recommends patients contact their health care providers if they have an Equinoxe Shoulder System and are experiencing new or worsening pain, swelling, an inability to use their arm, grinding or other noise, or weakness around the implant. However, patients may not require surgery to remove or replace the device if it is functioning without problems.

Since the manufacturer has not issued an Equinoxe shoulder recall, Doctors are being warned not to implant systems packaged in the defective bags, to monitor patients with the affected devices for signs of wear, failure and bone loss, and to discuss revision surgery with patients who are experiencing problems on a case-by-case basis.

The FDA safety communication includes a list of the Unique Device Identifier (UDI) numbers for affected implants.