FDA warns surgeons not to use certain Synovo Total Hip Resurfacing System

FDA warns surgeons not to use certain Synovo hip replacements

FDA: Synovo’s Total Hip Resurfacing System lacks proven effectiveness
Recommendations apply to patients who received certain implants after 2019
Surgeons should remove systems; monitor patients using them closely

Updated: Jan 4, 2024 / 08:54 AM CST

DENVER, CO – DECEMBER 2: Joseph’s pre-surgery x-ray shows the plan for his right hip replacement. Porter Adventist Hospital and their orthopedic surgeons opened their first day of joint replacement surgeries as a participating hospital for Operation Walk USA. Operation Walk USA is an independent medical humanitarian organization that provides free hip or knee replacement surgeries to needy patients in the U.S. The surgeries are provided for those who do not qualify for government assistance programs and cannot afford surgery on their own. Porter is one of 70 hospitals participating and the organization estimates that about 230 patients will receive free joint replacements nationwide. (Photo by Kathryn Scott Osler/The Denver Post via Getty Images)

(NewsNation) — The U.S. Food and Drug Administration (FDA) has recommended health care providers stop using the Total Hip System and its implants made by Synovo Production, Inc. after three components were “significantly modified” from the devices cleared by the agency.

The recommendations also apply to patients who received certain implants used in the system after 2019. The FDA explained the safety and effectiveness of the system and its three components — the femoral resurfacing cup, acetabular fixation cup, and acetabular bearing — have not been established.

Other names for the system include the total hip replacement system, Synovo Preserve and Endotec BP.

The FDA said it became aware of the modifications made to the components in 2022, and after an inspection, it issued a warning letter to Synovo. The letter listed several violations and instructed the company to “immediately stop” making the modified devices and correct the violations. The agency also requested Synovo notify customers of the risks associated with the devices.

The FDA said it will continue working with Synovo to bring the devices into compliance with its requirements.

The FDA advised health care providers not to purchase or implement the Synovo Total Hip System currently available. Surgeons should also remove all the systems, including affected implant components from inventory, the agency said.

Additionally, the FDA urged providers to closely monitor patients with the Synovo system for potential bone loss, device loosening, wear or failure.