FDA Exactech Implant Warning Urges Doctors to Monitor Patients for Failures, Need for Revision Surgery

More than one year after a massive Exactech recall that has resulted in hundreds of lawsuits against the manufacturer, the FDA is warning individuals and doctors about the continuing risks associated with the implants

Federal regulators are urging doctors to closely monitor patients with recalled Exactech joint replacements, due to the high risk of the devices failing and requiring revision surgery.

The U.S. Food and Drug Administration (FDA) issued an updated Exactech implant warning on March 23, providing a series of recommendations for doctors and patients to watch for signs of hip or knee replacement failure. However, the agency indicates that individuals who are not yet experiencing trouble with the implants do not need to seek revision surgery to have the recalled components removed or replaced.

An Exactech implant recall was issued 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 similar 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.

Since then, nearly 200 Exactech knee lawsuits and Exactech hip lawsuits have been filed and centralized before U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, since they each involve similar questions of fact and law about whether “out-of-specification” vacuum sealed bags caused a plastic tibial insert component to fail, leading to risky revision surgery.

As part of the management of the litigation, it is expected that Judge Garaufis will establish a “bellwether” process, where a small group of representative claims will go through a case-specific discovery process and be prepared for early test trials, which will help determine potential settlement values by gauging the average Exactech lawsuit payout awarded for recalled components

FDA Exactech Implant Warning

In the safety communication, the FDA reminded health care professionals and patients to be aware of the risk of Exactech implant failures, and detailed the problem with the packaging which led to the recall.

“The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time. Oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery,” the FDA warns. “Some of the recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure.”

However, the FDA recommended patients whose knee, ankle, or hip replacement implant was functioning well and causing no pain or symptoms do not need revision surgery to have the implants removed. The agency instead urged patients to contact their healthcare provider if they experience any worsening pain or swelling, an inability to bear weight, grinding or other noises, or weakness around the implant.

The FDA indicates that health care providers should not implant any of the recalled Exactech devices in patients, and called for them to monitor patients who had any Exactech implant manufactured between 2004 and August 2021 for potential wear, failure or bone loss.

The agency also recommended doctors consider performing X-rays if they suspect a patient has a failed Exactech implant. If problems such as worsening pain or weakness are detected, health care providers should discuss revision surgery with patients on a case-by-case basis.

Patients with an Exactech implant can check the manufacturer’s online database to see if their knee or ankle implant is included in the Exactech recall. Doctors and patients who experience problems with recalled Exactech implants are encouraged to report them through the MedWatch adverse event reporting program.