FDA Synovo Total Hip System Warning
The U.S. Food and Drug Administration (FDA) issued a January 2024 warning to Surgeons and Surgical Centers regarding Synovo Total Hip Replacement System Devices. Synovo Total Hip Replacement System components have also been sold as Synovo Preserve and Endotec BP.
The FDA warning advises that Synovo Total Hip System devices manufactured after 2018 should NOT be used in hip implant procedures and states that the devices may not meet FDA guidelines. The FDA recommends that devices should not be purchased or implanted and that they be removed from inventory due to a high risk of device failure.
Components which have been named in warnings include:
- Femoral Resurfacing Cup
- Acetabular Fixation Cup
- Acetabular Bearing
People who received a Synovo Total Hip Replacement System and experienced complications or required hip revision surgery may be eligible for compensation through a Synovo Hip Lawsuit.
Synovo Hip Devices Differed from Approved Versions
In an October 2022 inspection of Synovo facilities, the FDA determined that significant modifications had been made to the approved design of the Synovo Total Hip System devices in 2019. An FDA warning letter was issued to Synovo listing violations and required that the company discontinue manufacturing the unapproved devices.
Healthcare organizations, doctors and facilities were not notified until January 2024 when the FDA warned that the devices significantly differed from approved versions. The warning notification stated that the devices should not be implanted in patients and all remaining device components be removed from stock.
Synovo Hip System Complications
The FDA has warned that Synovo Total Hip System devices manufactured after 2018 should no longer be implanted and that these devices should be removed from surgical center and hospital supplies.
The FDA has not recommended that devices be removed from patients who have them, but higher-than-expected risk of complications and adverse events have been linked to use of the recalled Synovo Total Hip Replacement System components. Some patients may require revision surgery to address complications.
Patients have reported symptoms including:
- Worsening pain
- Loosening
- Grinding or other noises
- Inability to bear weight
- Weakness of hip
- Weakness of the knee
The FDA has recommended that patients who received Synovo Total Hip System devices should be closely monitored and that symptoms be reported to a health provider immediately. Patients who experience serious complications may require additional surgery to remove and replace Synovo Hip components.
People who received a Synovo Total Hip System, Synovo Preserve or Endotec BP hip replacement after 2018 and experienced severe complications or required hip revision surgery may be eligible for compensation.