The US Food and Drug Administration (FDA) has provided recommendations for healthcare providers who consider using the Total Hip System, including resurfacing implants, made by Synovo Production.
The Synovo Total Hip System is designed for patients receiving a total hip replacement, commonly known as total hip arthroplasty.
The FDA has also issued recommendations for patients who received certain implants used in the system after 2019.
Synovo has modified three components of the system, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, from the devices initially cleared by the health agency.
According to US FDA, the effectiveness and safety of the system and its three components have not been established.
The Total Hip System is also known as the Total Hip Replacement System, and also as Synovo Preserve and Endotec BP.
The FDA was informed in 2022 that the three components have undergone major changes. Following an inspection, the agency sent Synovo a warning letter.
Synovo was directed to stop producing the modified devices immediately and take immediate corrective action for the violations mentioned in the warning letter.
The American health regulator has asked that the business inform its customers of the risks connected to the modified devices.
The FDA and Synovo will keep collaborating to bring the devices into compliance with its regulations.
For affected patients, the agency has advised them to contact their healthcare provider if they feel new or worsening pain, inability to bear weight or weakness of the hip or knee on the side of their implant.
Furthermore, the FDA doesn’t recommend surgery for those whose implant functions well and experience no pain or deteriorating symptoms.
The US FDA suggested that healthcare providers not buy or implant the existing Synovo Total Hip System and remove the modified components from the inventory.
Additionally, the health regulator suggested them to closely monitor patients who received the Synovo Total Hip System for possible bone loss or device loosening, wear, or failure.
