Sam Brusco, Associate Editor01.04.24
The U.S. Food and Drug Administration issued a safety communication urging not to use Synovo’s Total Hip Resurfacing Systems manufactured after 2019.
The agency warned that three of the system’s components—the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing—were significantly modified from the devices that were initially cleared. Their safety and effectiveness haven’t been established.
The total hip system—also known as Synovo Preserve and Endotec BP—is used for patients receiving total hip replacement. The FDA said it became aware in 2022 that the modifications were made to the three components, at which point a Warning Letter was issued to Synovo. It listed multiple violations and instructed the company to immediately cease making the modified devices, as well as take prompt action to correct the violations.
Healthcare providers were urged not to purchase or implant the currently available system and remove any offending devices from their inventory. The FDA said patients should contact their doctor if symptoms like new or worsening pain, loosening, grinding or other noise, inability to bear weight, or weakness of the hip or knee on the side of the implant occur.
The FDA advised not to remove it from patients without worsening pain or symptoms and closely monitor patients with the system for potential bone loss or device loosening, wear, or failure.
The agency requested Synovo notify customers about the risks associated with modified devices and that it’s working with the company to bring devices into compliance.
The agency warned that three of the system’s components—the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing—were significantly modified from the devices that were initially cleared. Their safety and effectiveness haven’t been established.
The total hip system—also known as Synovo Preserve and Endotec BP—is used for patients receiving total hip replacement. The FDA said it became aware in 2022 that the modifications were made to the three components, at which point a Warning Letter was issued to Synovo. It listed multiple violations and instructed the company to immediately cease making the modified devices, as well as take prompt action to correct the violations.
Healthcare providers were urged not to purchase or implant the currently available system and remove any offending devices from their inventory. The FDA said patients should contact their doctor if symptoms like new or worsening pain, loosening, grinding or other noise, inability to bear weight, or weakness of the hip or knee on the side of the implant occur.
The FDA advised not to remove it from patients without worsening pain or symptoms and closely monitor patients with the system for potential bone loss or device loosening, wear, or failure.
The agency requested Synovo notify customers about the risks associated with modified devices and that it’s working with the company to bring devices into compliance.