FDA Warning: Do Not Use Synovo Total Hip System

The FDA has issued a warning about the Synovo Total Hip System, including resurfacing implants. The warning is for healthcare providers and patients who received these implants after 2019. Healthcare providers received a warning to avoid using the system and to remove it from their inventory.

What is the Synovo Total Hip System?

The Total Hip Resurfacing System is a three-piece plastic and metal joint replacement implant. Synovo Production, Inc. makes a total hip replacement system that includes a Femoral Resurfacing Cup, Acetabular Fixation Cup, and Acetabular Bearing. This is a fully porous ceramicized metal and polyethylene option available in different sizes.

The components are also sometimes sold and implanted separately.

Synovo Hip System Safety Issues 

The FDA is citing significant post-approval modifications. The primary modification is to the femoral resurfacing cup and involves coating specifications. They have now found modifications to the acetabular fixation cup and acetabular bearing as well.

As a note, there have not been any reported failures of the implant and the FDA is not recommending revision surgery to remove it. However, they are recommending patients watch for symptoms such as grinding or noise from the implant, weakness of the hip or knee on that side, difficulty bearing weight, or new or worsening pain. These might indicate implant failure.

The warning is precautionary because the modifications haven’t been properly tested and approved. In 2019, we made modifications to the system. If you installed the system before then, the warning does not apply, although all hip implant patients should watch for the mentioned symptoms.

FDA Recommendations for Healthcare Providers

The FDA has recommended that healthcare providers:

• Do not purchase the currently available Synovo Total Hip System.
• Do not implant it in patients, but rather use alternatives.
• Remove it and its components from the inventory.
• Monitor patients who have the system implanted.

Again, there is no recommendation to remove and replace the implant. This situation might change if we receive reports of significant implant failures, but the issue has already been present for a few years. This lessens but does not eliminate the chance of large numbers of premature failures, but issues may have shortened the lifespan of the implant.

Are You Having Issues With Your Device?

You might have problems with your implant if you have the following symptoms:

• New or worsening pain in your hip
• Your hip feels “loose” or unsteady.
• Any kind of grinding sound or other noise from your hip.
• Your hip feels weak.
• Your knee feels weak.
• Difficulty or inability to bear weight on that leg.

If you have any of these symptoms, you should talk to your healthcare provider. They can do X-rays and, if necessary, plan for revision surgery. Again, devices implanted before 2019 are not included in the warning.

You should also report the problem through the MedWatch voluntary reporting form. This is one of the ways the FDA tracks issues with medical devices and other products. Your healthcare provider may also have an obligation to report the issue.

Our Synovo Lawyers Can Help

If you’re experiencing negative side effects or need corrective surgery because of the Synovo hip system, you may be eligible for financial compensation. Talk to our legal team by filling out our contact form or by calling us at (800) 718-4658.