The U.S. Food and Drug Administration (FDA) issued a new statement warning orthopedic surgeons to remove the pharmaceutical company Synovo’s total hip replacement implants from their inventories and refrain from further purchasing the components of the implant, according to a report from Fierce Biotech. The statement came after the FDA became aware of modifications to Synovo’s implants in 2022 and subsequently sent the company a warning letter to immediately halt manufacturing. The implants have not undergone federal review since their initial clearance in 1991, when the company was cleared to use their femoral resurfacing cup with bone cement. However, recent modifications to the instructions for the cup specified a cementless fixation process—potentially increasing the risk of loosening parts and the need for revision surgery. The FDA provided recommendations for patients experiencing pain, weakness, and worsening symptoms who have received a Synovo femoral resurfacing cup, acetabular fixation cup, or acetabular bearing since 2019. Those without symptoms should undergo surveillance for bone loss or suspected device failure.
January 18, 2024