The U.S. Food and Drug Administration (FDA) is warning healthcare providers not to use the Synovo Total Hip System, a medical device for total hip replacements. According to a press release, three components have been modified in the system, which is also known as the Total Hip Replacement System, Synovo Preserve, and Endotec BP, since being cleared by the FDA. Last year, the agency issued a warning letter to Synovo ordering the manufacturer to stop manufacturing the Total Hip System because the device had been modified without FDA approval. The FDA has asked Synovo to notify its customers about the warning.
Synovo Total Hip System Problems
The FDA says that some elements of the hip replacement device — the Femoral Resurfacing Cup, Acetabular Fixation Cup, and Acetabular Bearing — have been modified since 2019. In the warning letter, the agency details how it discovered the modifications. In 2022, an FDA inspector visited a Synovo manufacturing facility in Fullerton, California. They found that the device’s femoral resurfacing cup component, which received FDA clearance in 1991, had been significantly changed in “design, components, method of manufacture, or intended use.”
The component was only cleared for cemented use, which is when an implant is secured by bone cement. But Synovo’s instructions say that the resurfacing cup can be used during cementless fixation, which is more common in the U.S. The FDA found that the device’s modifications could cause complications and increase the chance that someone might need revision surgery. The warning letter lists several violations, including failing to document personnel training, not conducting quality audits, failing to validate its manufacturing process, and not documenting design changes. The FDA required Synovo to respond to the letter within 15 business days detailing its planned steps to remedy the violations.
For Healthcare Providers
The FDA has multiple recommendations for healthcare professionals who provide hip replacements. First, healthcare workers should avoid purchasing the Synovo Total Hip System and remove it from inventory if the device has already been purchased. Providers shouldn’t remove the implant from patients without symptoms, but they should be closely monitored. The agency recommends ordering X-rays if device failure is suspected. Providers should also discuss the pros and cons of treatment options with patients before surgery.
If you have a Synovo Total Hip System and have experienced loosening, grinding, weakness on the same side of the body as your implant, or trouble bearing weight on the affected hip, you should contact your doctor. The FDA doesn’t recommend device removal if you have a Synovo implant but haven’t experienced any symptoms. However, you should remain alert of potential symptoms and contact a medical professional if you develop any problems associated with the device.
Hip replacement revision surgery is performed when there’s damage to the artificial implant. It is a complex procedure; recovery can take up to 18 months. Additionally, the surgery has an increased risk of complications, including infections, blood clots, fractures, and dislocation. Some patients with the Synovo Total Hip System may need hip replacement revision surgery because of problems caused by the medical device. If you have issues with your Synovo device, you should report it to the FDA through the MedWatch Voluntary Reporting Form.
Taking Legal Action for Synovo Hip Issues
If you have a Synovo Total Hip System and are experiencing symptoms, you may wonder whether you have legal recourse. Hip replacement revision surgery is expensive — some procedures cost up to $44,000 — and can significantly impact your quality of life. You should consider contacting an attorney to discuss your options because you may have grounds for a lawsuit. When you go to a doctor for a hip replacement, you assume that the devices they use are FDA approved and cleared for use. The effects can be devastating when that isn’t the case.
A lawsuit against Synovo could recover damages for losses like pain and suffering, medical expenses, and decreased enjoyment of life. Search for an attorney with experience with defective and dangerous product cases, and be wary of any lawyer who asks for payment upfront. These types of cases are usually handled on a contingency basis, meaning an attorney only gets paid if they win your case.