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FDA Safety Communication States, Do Not Use Synovo Total Hip Resurfacing System. 

An FDA Communication concerning Synovo Total Hip Resurfacing System came out today. It is titled, Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication | FDA

FDA provided recommendations for health care providers considering using the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo). This concerns patients who may have received certain implants used in the Synovo Total Hip System after 2019.

It appears the problem is post-market modifications to the design. In particular, FDA noted that the “safety and effectiveness have not been established for the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing used in the Synovo Total Hip System.” The FDA notice states further:

“Three components of the system, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, have been         significantly modified from the devices that were cleared by the FDA. The safety and effectiveness of the Synovo Total Hip System,               including the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, have not been established. The                 Synovo Total Hip System is also referred to as the Total Hip Replacement System, and also as Synovo Preserve and Endotec BP.”

FDA’s Recommendations for Patients Who Received Synovo Total Hip Resurfacing After 2019

First, FDA advises people who had a Synovo Total Hip Resurfacing contact their health care provider if they experience the following symptoms:

  • New or worsening pain;
  • Loosening;
  • Grinding or other noises;
  • Inability to bear weight, or weakness of the hip or knee on the side of your implant.

Second, FDA notes that if the “hip implant is functioning and you have no pain or worsening symptoms, the FDA does not recommend surgery to remove this device. Please continue the follow up schedule recommended by your health care provider.”

FDA Recommended Healthcare Providers Do Not Implant the Synovo Total Hip System 

FDA advised removal of existing inventories. Specifically, “all Synovo Total Hip Systems, including the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing components used in the system.” Additionally, FDA recommends healthcare providers:

  • “Discuss with patients considering hip implants the benefits and risks of all relevant treatment options, including alternative legally marketed hip implant devices.
  • Closely monitor patients who have the Synovo Total Hip System, including resurfacing implants, for potential bone loss or device loosening, wear or failure. Consider obtaining X-rays to further evaluate a patient and their implanted device if you suspect device failure.
  • Review the above ‘Recommendations for Patients’ with patients who have received any components of the Synovo Total Hip System.”

FDA’s Action Arises from Information FDA Obtained in 2022 and an Inspection

The Notice states that “FDA became aware in 2022 that significant modifications had been made to the Synovo Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing.” FDA conducted an inspection. Then, FDA issued the medical device manufacturer, Synovo, a Warning Letter identifying several violations. FDA “instructed the company to immediately stop manufacturing the modified devices and take prompt action to correct the violations addressed in the letter.”

What Comes Next?

FDA requested Synovo notify its customers of device risks while it continues to work with the company “to bring its devices into compliance with FDA requirements. The FDA will also continue to keep the public informed if significant new information becomes available.”

You can report problems with the device here, MedWatch Voluntary Reporting Form.

Potential Medical Device Litigation 

It is our understanding that to sell most medical devices in America, companies must go through the FDA in advance. There are generally two pathways to a product getting on the market – FDA approval and FDA clearance.

The first is through a premarket approval process. This usually includes clinical studies. By comparison, the clearance process, which we often reference by the statutory citation, 510(k), is often less rigorous. Essentially companies show their product is substantially equivalent to a predicate device on the market.

Either way, if a company changes the product significantly after FDA evaluates it without informing FDA, that could violate FDA regulations. Misbranding may come into play, which can bring serious consequences. Put simply, what may have happened here is that the company changed the designed of the product. Those changes may introduce new or additional risks of injury like pain, inability to bear weight, or weakness of the hip or knee. It may cause loosening that can lead to injuries. We have seen this issue with other medical devices.

UPDATE: Media Coverage

This is picking up steam in the press. Reported in various places already.

 

Contact KBA Attorneys

It is too soon to tell if there are potential claims here, but the attorneys at KBA will be investigating this further. Contact us today if you would like to learn more.

(Note: KBA is not providing medical advice and is not advising anyone to stop using devices. Patients should peak with a medical professional and healthcare providers should contact FDA.)