FDA Warns Against Using Synovo Total Hip System

FDA recently published a safety communication recommending healthcare providers not use Synovo Production’s Total Hip System, which includes three components: the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing due to significant unapproved modifications. Additionally, they provided the same statement for patients who may have received certain implants used in the total hip system after 2019.

FDA said the safety communication follows an inspection in 2022 which uncovered significant modifications made to all three system components without regulatory approval. At the time of the inspection, the agency issued the company a warning letter which listed several violations and instructed the company to immediately stop manufacturing the modified devices as well as take action to correct cited issues. The company was also told to notify its customers of the risks associated with the modified devices.

Currently, according to FDA, safety and effectiveness has not been established for the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing used in the total hip system.

The Synovo Total Hip System, which includes resurfacing implants, is used in patients receiving a total hip replacement. During implantation, the system may use components like the Acetabular Fixation Cup and/or the Acetabular Bearing along with a conventional femoral stem and head component.

For healthcare providers, FDA recommended not purchasing or implanting the currently available system and removing it from inventory — including all three components used in the system. Of note, it is not recommended at this time to remove the device from patients who are not experiencing new or worsening pain and symptoms. However, they did suggest providers continue to monitor patients 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,” according to the safety communication.

When discussing potential hip implants with patients, the agency also recommended helping patients understand the benefits and risks of all treatment options, including legally marketed hip implants.

For patients who may have received the device after 2019, FDA said to contact a healthcare provider if there are any symptoms like new or worsening pain, loosening, grinding, or other noise, inability to bear weight, or weakness of the hip or knee on the side of the implant. Additionally, they recommended continuing the follow-up schedule set by a healthcare provider.

 FDA said it will continue to keep the public informed of any new significant information.