On January 3, 2024, the FDA issued a safety communication warning regarding the Synovo Total Hip System, Total Hip Replacement System, Synovo Preserve and Endotec BP. According to the FDA, oarts of the Hip System including the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, have been significantly modified from the devices that were cleared by the FDA. Therefore, the safety and effectiveness of the device has not been established.
The hip system was manufactured by Synovo Production, Inc. Synovo was previously warned by the FDA in March 2023 that its product was adulterated. See warning letter here. (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synovo-production-inc-647427-03232023)
If you are experiencing any of the following after implant of the Synovo Total Hip System please call or email us today:
- New or worsening pain
- Loosening, grinding, or other noise
- Inability to bear weight
- Weakness of the hip or knee on the side of the implant
- Revision or replacement surgery