In recent years, individuals who underwent hip replacement surgery using Synovo's modified components have found themselves facing unexpected challenges. The FDA has identified three modified components, which must have been manufactured after 2019, raising concerns about the safety of Synovo's hip replacement systems.
The FDA's alert specifically targets three modified components: the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing. The modifications took place in 2019, making it crucial for individuals who received hip replacements with these components to be aware of potential risks.
The FDA's warning letter shows in detail the significant changes Synovo made to the Femoral Resurfacing Cup, replacing the porous underside coating with a cement-less coating. The modified devices were then distributed without the necessary documentation or proper FDA premarket approval, which raised serious concerns from the FDA.
In response to the findings during the facility inspection, the FDA recommended healthcare providers to avoid purchasing the currently available Synovo Total Hip System and advised the removal of any existing Total Hip Systems or components from inventory. Healthcare providers are asked to consider alternative hip replacement implant devices for future hip replacement surgeries.
Hip replacement failures have become a growing concern for patients seeking relief from hip pain and injuries. Attorneys are actively representing individuals who have suffered from hip replacement failures.
Physicians often utilize hip replacement devices to address hip-related issues, including resurfacing procedures. While artificial hips are designed to last up to 20 years, instances of failure do occur. The inclusion of Synovo stems from the FDA's recent warning against the Synovo Total Hip Resurfacing, emphasizing the importance of scrutinizing cases related to this particular brand.
As of February 2024, discussions about filed Synovo lawsuits related to hip replacements are circulating. Attorneys are actively monitoring developments in Synovo lawsuits and the affected can seek legal counsel to know the prospects of their claims.
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