The FDA today issued recommendations for providers considering using the Total Hip System and its implants made by Synovo.
Its recommendations also apply to patients who received certain implants used in the system after 2019. Three components — the femoral resurfacing cup, acetabular fixation cup and acetabular bearing — have been significantly modified from the devices initially cleared by the FDA, the agency’s notice said.
According to the FDA, the safety and effectiveness of the system and its components have not been established. Other names for the system include the total hip replacement system, Synovo Preserve and Endotec BP.
The FDA became aware of the modifications made to the components in 2022. Following an inspection, the agency issued a warning letter to Synovo. The letter listed several violations and instructed the company to immediately stop manufacturing the modified devices. The FDA urged the company to take prompt action and correct the listed violations.
Additionally, the FDA requested that the company notify customers of the risks associated with the devices. It plans to continue working with Synovo to bring the devices into compliance with its requirements.
For potentially affected patients, FDA suggests contacting a healthcare provider if they feel new or worsening pain, loosening or grinding. Other red flags include other noises, inability to bear weight or weakness of the hip or knee on the implant side. If the implant functions fine and the patient experiences no pain or worsening symptoms, the FDA doesn’t recommend surgery.
The FDA advised healthcare providers to not purchase or implant the currently available Synovo Total Hip System. They should also remove all the systems, including affected implant components, from inventory. Additionally, providers should closely monitor patients with the Synovo system for potential bone loss, device loosening, wear or failure.
