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FDA Safety Communication : Do Not Use Synovo Total Hip Resurfacing System
FDA Safety Communication: Do Not Use Synovo Total Hip Resurfacing System
Introduction:
In a significant and urgent notice, the Food and Drug Administration (FDA) has issued a recommendation for healthcare providers to cease the purchase and implantation of Synovo Production Inc.’s total hip replacement system. The regulatory body has gone further, advising orthopedic surgeons to remove all components of this system from their inventories due to substantial modifications made over the past 30+ years.
FDA Safety Communication Link (1/3/2024):
Do Not Use Synovo Total Hip Resurfacing System
FDA Warning Letter Link (3/23/2023):
Warning Letter Scope:
Implants manufactured by Synovo Production, Inc. after 2019 and patients who may have received certain implants used in the Synovo Total Hip System after 2019.
Introduction:
In a significant and urgent notice, the Food and Drug Administration (FDA) has issued a recommendation for healthcare providers to cease the purchase and implantation of Synovo Production Inc.’s total hip replacement system. The regulatory body has gone further, advising orthopedic surgeons to remove all components of this system from their inventories due to substantial modifications made over the past 30+ years.
FDA Safety Communication Link (1/3/2024):
Do Not Use Synovo Total Hip Resurfacing System
FDA Warning Letter Link (3/23/2023):
Warning Letter Scope:
Implants manufactured by Synovo Production, Inc. after 2019 and patients who may have received certain implants used in the Synovo Total Hip System after 2019.
FDA’s Recommendations:
The FDA’s alert underscores the evolving nature of medical technology, as it emphasizes that parts of Synovo’s implant have undergone significant changes since its initial federal review and regulatory clearance back in 1991. The affected components include the femoral resurfacing cup, acetabular fixation cup, and acetabular bearings, some of which are marketed as stand-alone products. The total hip system is also known by the names Synovo Preserve and Endotec BP.
The revelation came to light as the FDA became aware of crucial hardware modifications in 2022, leading to the issuance of a warning letter to Synovo in March 2023. Inspectors highlighted alterations in the femoral resurfacing cup, which had initially received clearance with a stipulation against promotion for use without bone cement. Shockingly, subsequent instructions indicated a coating that enabled usage in cementless fixation, deviating from the original clearance.
The warning letter expressed grave concerns, stating, “The referenced changes, individually and collectively, are likely to expose patients to increased risks of loosening and subsequent revision surgery (e.g., from pain, proximal femur fracture, or component fracture).”
In response to these revelations, the FDA, in its January 3 notice, recommended against the surgical removal of Synovo Total Hip Systems for patients without new or worsening pain or symptoms. However, the agency emphasized the importance of vigilant monitoring for potential complications, including bone loss, implant loosening, or suspected device failure through methods such as X-rays.
Patients who have undergone procedures involving Synovo’s femoral resurfacing cup, acetabular fixation cup, or acetabular bearings since 2019 are advised to stay vigilant. Warning signs, such as new or worsening pain, grinding, unusual noises, or weakness in the hip or knee on the side of the implant, should prompt immediate contact with healthcare providers.
Reporting Problems with Your Device:
If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.