FDA Tells Clinicians to Stop Using Synovo’s Modified Total Hip System

The FDA has issued a warning to patients and health care providers to not use the Synovo Total Hip System including resurfacing implants, manufactured by Synovo Production after 2019, because components of the system have been modified from the cleared device and the safety and effectiveness has not been established.

In 2022, the FDA’s warning says, the agency became aware that significant modifications had been made to three parts of the Synovo Total Hip System: the Synovo femoral resurfacing cup, the acetabular fixation cup, and the acetabular bearing.

Health care providers have been advised not to purchase or implant the currently available Synovo Total Hip System and to remove all components of the system from inventory. The FDA does not recommend removal of the systems from patients who do not have any new or worsening pain or symptoms.

Read the FDA safety communication here.

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