Dive Brief:
- Exactech, an orthopedic implants maker, received a warning letter related to its handling of packaging problems that could cause its implants to degrade faster.
- The Food and Drug Administration sent the warning letter to Exactech on Jan. 19, days after alerting healthcare providers not to implant the company’s Equinoxe Shoulder Systems that were packaged in defective bags. The problem could cause patients to need revision surgery to replace or correct the affected devices.
- The FDA made the letter public on Tuesday. The agency uses warning letters to notify manufacturers of significant violations that could lead to enforcement action if not corrected.
Dive Insight:
Exactech’s implants were packaged in bags that were missing one of the barrier layers that can protect the devices from oxidation, which can cause plastic components to degrade over time, the FDA said in its January notice.
At the time, the agency said Exactech had declined to issue a voluntary recall of the Equinoxe Shoulder System implants that had been packaged in the defective bags. The implants were manufactured between 2004 and 2021.
The agency sent a warning letter to Exactech CEO Darin Johnson after an inspection of the company’s Gainesville, Florida, headquarters in September 2023.
The inspection found the company did not identify actions to correct the problem with how it packaged its shoulder implants. Specifically, the FDA said Exactech did not evaluate all of the data to determine if a correction and removal was needed.
In an analysis of complaints from 2008 to 2021, Exactech only included data showing polyethylene wear, citing 11 total complaints. The company should have also included complaints about instability, pain, joint dislocation and loss of range of motion, which can be signs of a degraded implant, the FDA said.
The agency also found that Exactech waited months to submit adverse event reports, which typically must be submitted to the FDA within 30 days. For example, Exactech became aware of a report in September 2022 that suggested a patient needed revision surgery because a hip implant exhibited accelerated wear due to the non-conforming packaging. The FDA received the report in January 2023.
The company recalled hip, knee and ankle implants in 2021 and 2022 because of the same packaging problem.
Exactech responded to the inspection findings in October, saying the company would conduct a retrospective review of complaints, revise its procedures for addressing complaint coding, and offer training to staff.
However, the FDA found the adequacy of that response “cannot be determined at this time,” as Exactech did not provide specific details on the results of its corrective actions.