The safety notice, released on January 4, 2024, highlights significant modifications made to components of Synovo’s system, raising concerns about the safety and effectiveness of the product. This warning follows a letter sent to Synovo in March 2023, where the FDA discovered substantial changes to the femoral resurfacing cup, a part of the system, since its initial 510(k) clearance in 1991.
The FDA has specifically identified three components of the Synovo Total Hip System—the femoral resurfacing cup, acetabular fixation cup, and acetabular bearing—as having undergone significant modifications. Due to these changes, the FDA concludes that Synovo has not established the safety and effectiveness of the system. Consequently, the agency strongly recommends against purchasing or implanting the current version of the Synovo Total Hip System and has instructed Synovo to cease manufacturing the system immediately.
Healthcare providers are urged to remove the Synovo Total Hip System and its three modified components from their inventory. While the FDA advises against removing the system from patients without new or worsening pain or symptoms, healthcare professionals are instructed to closely monitor individuals for potential issues such as bone loss, device loosening, wear, or failure. The FDA has also requested Synovo to notify its customers about the risks associated with the modified devices and is collaborating with the company to bring the devices into compliance with regulatory standards.