FDA advises against use of THA system due to significant modification
Key takeaways:
- The FDA released a safety communication due to significant modification of the Synovo Total Hip System.
- The FDA recommends against the purchase or implantation of the currently available Synovo Total Hip System.
The FDA released a safety communication on the Synovo Total Hip System, manufactured by Synovo Production Inc., due to significant modification of the femoral resurfacing cup, acetabular fixation cup and acetabular bearing.
Because of these modifications, the safety and effectiveness of the femoral resurfacing cup, acetabular fixation cup and acetabular bearing components used in the system have not been established. According to the FDA safety communication, the Synovo Total Hip System is also known as the Total Hip Replacement System and also referred as Synovo Preserve and Endotec BP. The FDA recommends that health care providers not purchase or implant the currently available Synovo Total Hip System and remove all Synovo Total Hip Systems, including the femoral resurfacing cup, acetabular fixation cup and acetabular bearing components, used in the system from inventory. Health care providers should also closely monitor patients who have the Synovo Total Hip System for potential bone loss or device loosening, wear or failure. However, the safety communication does not recommend removal of the Synovo Total Hip System from patients who do not have any new or worsening pain or symptoms.
Patients who may have received the Synovo Total Hip System should contact their health care provider with any symptoms, including 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.
Any problems with the Synovo Total Hip System should be reported through the MedWatch Voluntary Reporting Form.
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