FDA Safety Communication

Date Issued: January 3, 2024

The U.S. Food and Drug Administration (FDA) is providing recommendations for healthcare providers considering using the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo) and for patients who may have received certain implants used in the Synovo Total Hip System after 2019. 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.

Recommendations for Patients Who May Have Received these Devices after 2019

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

• If your 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.

Recommendations for Health Care Providers

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

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

• Based on currently available information, the FDA does not recommend removal of Synovo Total Hip Systems from patients who do not have any new or worsening pain or symptoms.

• Be aware that 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.

• 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.

Device Description

The Synovo Total Hip System, including resurfacing implants, is used in patients receiving a total hip replacement, also referred to as total hip arthroplasty. The Synovo Total Hip System includes at least three components, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing used together. The Synovo Total Hip System may use the Acetabular Fixation Cup and/or the Acetabular Bearing along with a conventional femoral stem and head component.

FDA Actions

The 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. Following an inspection, the FDA issued a Warning Letter.

The Warning Letter listed several violations and instructed the company to immediately stop manufacturing the modified devices and take prompt action to correct the violations addressed in the letter. The FDA has requested that the company notify its customers (consignees) of the risks associated with the modified devices. The FDA will continue to work with Synovo 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.

Reporting Problems with Your Device

If you think you have a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Healthcare personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) or call 800-638-2041 or 301-796-7100.