FDA Warns Health Care Providers And Patients Not to Use Synovo Total Hip Resurfacing System

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FDA Warns Health Care Providers And Patients Not to Use Synovo Total Hip Resurfacing System

The U.S. Food and Drug Administration (FDA) has issued a safety communication warning healthcare providers and patients to avoid using the Synovo Total Hip Resurfacing System due to significant modifications to its components. The affected components include the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing. These modifications have not been proven for safety and effectiveness, raising serious concerns about patient health.

Recommendations for Patients Who May Have Received these Devices after 2019:

1. Contact your health care provider immediately if you experience symptoms such as new or worsening pain, loosening, grinding, inability to bear weight, or weakness in the hip or knee on the side of the implant.

2. If your hip implant is functional and you are symptom-free, the FDA does not recommend surgery to remove the device. Continue with the follow-up schedule advised by your health care provider.

Recommendations for Health Care Providers:

1. Do not purchase or implant the currently available Synovo Total Hip System.

2. Remove all Synovo Total Hip Systems from inventory, including the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing components.

3. The FDA does not recommend removing Synovo Total Hip Systems from patients without new or worsening pain or symptoms.

4. Be aware that safety and effectiveness have not been established for the modified components.

5. Discuss the benefits and risks of all relevant treatment options, including alternative legally marketed hip implant devices, with patients considering hip implants.

6. Monitor patients with the Synovo Total Hip System for potential bone loss, device loosening, wear, or failure. Consider obtaining X-rays if device failure is suspected.

7. Review the recommendations for patients with those who have received any components of the Synovo Total Hip System.

Device Description: The Synovo Total Hip System, including resurfacing implants, is used in total hip replacement (total hip arthroplasty). It consists of at least three components: the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing.

FDA Actions: The FDA discovered significant modifications to the Synovo Femoral Resurfacing Cup, Acetabular Fixation Cup, and Acetabular Bearing in 2022. Following an inspection, the FDA issued a Warning Letter to Synovo, instructing the company to cease manufacturing the modified devices immediately and correct the identified violations. The FDA has requested Synovo to notify its customers of the associated risks and will collaborate with the company to ensure compliance with FDA requirements.

Reporting Problems with Your Device: Patients experiencing issues with the Synovo Total Hip System are encouraged to report problems through the MedWatch Voluntary Reporting Form. Healthcare personnel should follow reporting procedures established by their facilities.

Questions? For inquiries, contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100. The FDA remains committed to keeping the public informed of any significant new developments related to the Synovo Total Hip Resurfacing System.