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The FDA issued a Safety Warning after a study found that 28% of patients needed revision surgery for problems with the Hintermann Series H3 Total Ankle Replacement.
Need a Texas H3 Ankle Replacement Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were injured or needed surgery for a Hintermann Series H3 Ankle Replacement, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
FDA Safety Warning for Hintermann Series H3 Total Ankle Replacement
In February 2024, the FDA published a Safety Warning because the “Hintermann Series H3 Total Ankle Replacement has a higher-than-expected risk of device failure.” This ankle implant is manufactured by DT MedTech LLC.
What Happened?
During clinical trials before the H3 Ankle Replacement was approved, studies showed that only 9.9% of patients needed additional surgery.
After the H3 Ankle Replacement was approved, the FDA required a follow-up study to look at real-world outcomes for patients who were implanted with the device. The study enrolled 298 patients. Unfortunately, at least 28.5% of patients needed another surgery to replace broken metal and/or plastic parts, according to the study.
How Many Patients Needed Another Surgery?
The post-approval safety study included 298 people who were implanted with the Hintermann Series H3 Total Ankle Replacement.
“When all types of revisions are included in the interim PAS results (such as revisions of the plastic component as well as the metal component), the rate of additional surgery is at least 28.5%.”
What Should I Do?
The FDA does not recommend surgery to remove the H3 Total Ankle Replacement if it is functioning well.
However, patients should contact a healthcare provider if they are experiencing problems with the H3 Total Ankle Replacement, such as:
- Ankle pain or swelling
- New or worsening pain and swelling
- Unable to use the ankle
- Unable to put weight on the ankle
- Grinding or other unusual noise
- Weakness around the ankle implant
How Will Doctors Diagnose the Problem?
Patients who are suffering from pain and other problems may need revision surgery for their H3 Total Ankle Replacement. Patients may need X-rays and/or a CT scan to check if the metal and plastic components in your Hintermann Series H3 TAR system are broken.
What is the H3 Ankle Replacement?
Total ankle replacement is a joint surgery that replaces damaged bones in the ankle with an artificial joint. DT MedTech manufactures the Hintermann Series® H3 Total Ankle Replacement System, a non-cemented implant to replace a painful arthritic ankle joint due to arthritis.
Need an H3 Ankle Replacement Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
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