Due to a significant modifications to the Synovo Total Hip Resurfacing System, including resurfacing implants, by Synovo Production, Inc., the FDA is advising healthcare providers against use of the device. The agency’s January 3, 2024 announcement also outlines recommendations for patients who may have already received specific implants that were part of included in the Synovo Total Hip System after 2019, when three components of the system were altered.
Officials say modifications to Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing have not been evaluated and cleared by the FDA, and therefore the safety and effectiveness of the components have not been established.
Also known as the Total Hip Replacement System, as well as Synovo Preserve and Endotec BP, the Synovo Total Hip System, which includes resurfacing implants, is implemented patients receiving total hip replacement (total hip arthroplasty). The system relies on at least three components–the Femoral Resurfacing Cup, the Acetabular Fixatio Cup, and the Acetabular Bearing–working in concert. The Acetabular Fixation Cup and or the Acetabular Bearing can also be paired with a “conventional femoral stem and head component.”
Following an inspection of the system in 2022, the FDA learned of “significant modifications” to the Synovo Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing. Shortly after, the agency sent a Warning Letter which detailed the multiple violations and instructed Synovo to have its products brought back into compliance with the established FDA requirements. The agency will keep the public apprised of new information as it continues to monitor the problem.
For patients who received the affected devices after 2019, the FDA had the following recommendations:
- Consult a healthcare provider in the event of such symptoms like “new or worsening pain, loosening, grinding or other noise, inability to bear weight, or weakness of the hip or knee” along the implant side.
- In the event that a hip implant is functioning and there is “no pain or worsening symptoms,” patients are advised to refrain from surgery to remove the device. The patient should adhere to the follow-up schedule as established by their healthcare professional.
For healthcare providers, recommended the following:
- Refrain from purchasing or implanting the Synovo Total Hip System that is currently available.
- Take the Synovo Total Systems, including all of its components–the Femoal Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing–out of inventory
- If a patient has received a Synovo Total Hip System and does not have any new or worsening pain/symptoms, removal of the system is not advised.
- Ensure that all relevant staff members are aware that the safety and effectiveness of the system’s modified components have not been established.
- Ensure that all prospective hip implant patients are aware of the benefits and risks of all treatment options, including any “alternative legally marketed hip implant devices.”
- Patients who have received the Synovo Total Hip System (including resurfacing implants) should be closely monitored for any bone loss, as well as any loosening, wear, or failure of the device. In the event that device failure is suspected, X-rays should be considered to further assess the patient and their implant.
- Be sure to review the “Recommendations for Patients,” as outlined in the FDA announcement, for patients who have already received one or more component of the Synovo Total Hip System.
In addition to the Warning Letter issue to Synovo upon learning of the unapproved modifications to the device, the FDA also instructed the company to alert its customers of all the known risks posed by the modified components.
Consumers and medical professionals alike are urged to report any related adverse events to the FDA’s MedWatch program. Those employed by facilities that follow the FDA’s user facility reporting requirements should comply to their facility’s established protocols.
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