The FDA issued a warning about the Hintermann Series H3 Total Ankle Replacement after a study found that 28% of patients needed revision surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting H3 Ankle Replacement induced injury cases in all 50 states. If you or somebody you know was injured or needed surgery for an H3 Ankle Replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
FDA Safety Warning for Hintermann Series H3 Total Ankle Replacement
In February 2024, the FDA issued a Safety Communication to warn patients about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement Series, manufactured by DT MedTech LLC.
What Happened?
A post-approval safety study involving 298 people with the H3 Total Ankle Replacement found a high rate of failure.
The study showed a revision rate of at least 16.1% (48/298 patients), which included additional surgery to remove the ankle replacement or revision of the metal components.
The revision rate was at least 28.5% (85/298) when all types of revisions were included (such as revisions of the plastic component as well as the metal component), according to the FDA.
What Should I Do?
For patients with an H3 Ankle Replacement that is functioning well, and with no new pain or worsening symptoms, the FDA does not recommend surgery to remove it.
Patients who are experiencing problems with their H3 Ankle Replacement should contact a healthcare provider. The patient may need to undergo a physical exam, X-rays, and possibly a CT scan to check if the plastic component in the H3 Ankle Replacement is broken.
Signs & Symptoms of Problems With H3 Ankle Replacements
- New or worsening pain or swelling
- Inability to use the ankle or put weight on it
- Grinding or other noise
- Weakness around the ankle replacement
Do I have an H3 Ankle Replacement Lawsuit?
The Schmidt Firm, PLLC is currently accepting H3 Ankle Replacement induced injury cases in all 50 states. If you or somebody you know was injured or needed surgery for an H3 Ankle Replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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