Dive Brief:
- The Food and Drug Administration has told healthcare professionals not to buy or implant Synovo Production’s Total Hip System.
- The safety notice, published Wednesday, warns that significant modifications to components of Synovo’s system mean its safety and effectiveness have not been established.
- The FDA sent a warning letter to Synovo in March 2023 after finding that its femoral resurfacing cup had been “significantly changed or modified” since receiving 510(k) clearance in 1991.
Dive Insight:
Last year, the FDA issued several warning letters that accused medtech companies, including Abbott and iRhythm Technologies, of making major changes to products without seeking 510(k) clearance. The series of actions included a warning letter that accused Synovo of making “a change to the coating specifications and associated differences in intended use” that could increase risk to patients.
Now, the FDA has followed up with recommendations for healthcare providers who are considering using Synovo’s Total Hip System, which is used in patients receiving a total hip replacement. The agency said three components of the system — the femoral resurfacing cup, acetabular fixation cup and acetabular bearing — have been significantly modified from the devices that were cleared.
As such, the FDA concluded Synovo has yet to establish the safety and effectiveness of the system. That view underpins the agency’s recommendation against buying or implanting “the currently available Synovo Total Hip System.” The warning letter told Synovo to “immediately” stop manufacturing the system.
The agency has now asked healthcare professionals to remove the systems and three underlying components from inventory. The FDA is advising against removing the system from people without “new or worsening pain or symptoms” but is also asking healthcare professionals to closely monitor patients for “potential bone loss or device loosening, wear or failure.”
The FDA requested that Synovo notify its customers of the risks associated with the modified devices and will continue to work with the company to bring the devices into compliance.