The FDA Issued a Safety Communication About the Synovo Total Hip Resurfacing System

Doctors sometimes perform total hip arthroplasty or total hip replacement using the Synovo Total Hip System, which features resurfacing implants. The United States Food and Drug Administration (FDA) has recommended that health care providers not use Synovo Total Hip Resurfacing System. While it’s also advised that the hip systems be removed under certain conditions of pain or other symptoms, the FDA does not recommend removal of implanted Synovo Total Hip Systems, if patients find their hip implant is working and they don’t have new or increasing symptoms or pain. If you were injured by the Synovo Total Hip System, you should call the seasoned Chicago-based product liability lawyers of Moll Law Group to learn your options. Billions have been recovered in cases with which we’ve been involved.

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There are three parts to the Synovo Total Hip System: the Acetabular Bearing, the Acetabular Fixation Cup, and the Femoral Resurfacing Cup. They are used together in the system. In 2022, the FDA found out that these three components had been significantly modified, such that it no longer followed the specifications originally improved by the FDA. It issued a warning to Synovo specifying the violations and telling the manufacturer it needed to stop making modified devices and act quickly to correct its legal violations.

The FDA has specifically asked that providers not buy or implant the Synovo Total Hip System and warn they should remove from inventory all the Synovo Total Hip Systems including the Acetabular Bearing components, Acetabular Fixation Cup, and the Femoral Resurfacing Cup. Moreover, The FDA asks consumers to get in touch with their doctors if they experience any symptoms in connection with the system such as weakness of the hip or knee, new or worsening pain, loosening, grinding, or inability to bear weight.

The FDA has also asked Synovo to let all its customers know what risks are linked to the modified medical devices and has agreed to work with the company to make its products comply with the agency’s requirements. It asks that you report any problems through a MedWatch voluntary reporting form. Meanwhile health care providers that work for facilities that are expected to follow the FDA’s user facility reporting mandates. Providers are also asked to talk with patients about the benefits and risks of hip treatments, including alternative devices to Synovo. If you have a Synovo total hip system, you should be closely monitored to make sure the device doesn’t loosen, become degraded or fail. Under some circumstances, it may be appropriate for your provider to obtain X-rays to see if the device has failed.

Those who have already been harmed by the unsanctioned modifications to the Synovo total hip resurfacing system may be able to recover damages by bringing a product liability lawsuit. In a product liability lawsuit, our attorneys would need to show that the system has manufacturing, design, or marketing defects. It’s important to get an expert on board to look at what type of defects are at issue and whether you were injured or harmed because of them. When liability can be shown under theories of strict liability, negligence, breach of warranty, breach of contract, or even, sometimes, medical malpractice, we can recover compensatory damages, and in cases of egregious manufacturer conduct, punitive damages, as well.

If you or a loved one were injured by the Synovo total hip resurfacing system, call the seasoned Chicago-based medical device lawyers of Moll Law Group for a consultation to talk about your legal options. We represent injured plaintiffs and grieving families across the country. Please complete our online form or call us at 312.462.1700.