Exactech Gets FDA Warning Letter Over Packaging Defects That Led to Implant Recalls, Lawsuits

FDA investigators found that Exactech failed take proper corrective actions to address packaging defects that caused joint replacement recalls and Exactech knee, hip and ankle implants to fail

Exactech has received an FDA warning letter over repeated problems with the packaging of joint replacement implants, which have resulted in a number of massive recalls and hundreds of Exactech lawsuits over device failures.

Problems with defective “out-of-specification” packaging first 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.

Earlier this year the U.S. Food and Drug Administration (FDA) also issued an Exactech Equinoxe Shoulder System implant warning, due to the same packaging problems.

As a result of problems linked to the defective components, 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.

Exactech Packaging Defects Warning Letter

On March 12, the FDA released a copy of a warning letter it issued to Exactech near the beginning of the year, after inspections conducted in relation to the Equinoxe shoulder implant warning found that the devices are adulterated under federal law.

The FDA letter indicates that Exactech failed to establish proper procedures to correct and prevent the packaging problems.

“Your firm has not identified actions needed to correct polyethylene shoulder implants packaged in vacuum bags that did not meet material specifications or oxygen transmission rate requirements,” the FDA warning letter states. “When calculating health risk of polyethylene shoulder implants impacted by nonconforming packaging to determine if a correction and removal was needed, your firm did not evaluate all applicable complaint data and failure codes in your Health Hazard Evaluation analysis.”

While Exactech told the agency it has begun systemic corrections of the problem, the FDA indicated that the adequacy of those efforts cannot yet be determined, noting that the company’s response did not provide enough specific information on the results of the corrective actions, which are still ongoing.

Exactech Joint Failures Were Not Adequately Addressed

The FDA investigators also determined that that Exactech had failed to establish and maintain design validation procedures to make certain its risk analysis was accurate and adequately evaluate the health risks of the defective packaging.

The agency noted that the packaging errors have led to the devices degrading on shelves, resulting in:

• Instability
• Subluxation of Joint
• Loss of Range of Motion
• Subsidence
• Migration
• Pain
• Total Joint Dislocation

The FDA also found the company has failed to standardize its review process, and failed to submit medical device reports linked to the defective packaging problem in a timely manner.

The letter called for a response from Exactech within 15 days of receiving the letter, which was originally sent out on January 19. The contents of the company’s response have yet to be revealed by the agency.

March 2024 Exactech Lawsuit Updates

Exactech faces more than 1,100 product liability lawsuits throughout the federal court system, with more than 400 additional cases spread across different state courts nationwide, each raising similar allegations that manufacturing defects caused the joint implants to fail prematurely.

Given common questions of fact and law raised in the complaints filed throughout the federal court system, consolidated pretrial proceedings have been established before U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, for coordinated discovery and pretrial proceedings.

As part of the management for the growing litigation, Judge Garaufis has established a bellwether process, where small groups of claims involving allegations that have been repeated throughout a large number of other claims will be prepared for a series of early trial dates, to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims.

The first Exactech knee replacement lawsuit trial is scheduled to begin on June 2, with a second bellwether trial set to begin on August 5, 2025.

Although the outcomes of any bellwether trials will have no binding impact on other lawsuits in the litigation, they will be closely watched and may have a large impact on any Exactech recall settlements the manufacturer offers to avoid the need for hundreds of individual trials to be scheduled in the coming years.