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Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure

  • February 29, 2024
  • KBA Attorneys
  • No Comments

KBA Attorneys litigates medical device cases. In particular, we have handled several orthopedic cases. Right now, we’re working on several hips and knees, like Exactech.

FDA Announces Hintermann Series H3 Total Ankle Fails More than Expected.

The FDA alerted “patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system, manufactured by DT MedTech LLC.” FDA analyzed results from a study. The results are pretty startling:

“additional surgery (removals or revisions of metal components, at least 16.1%) associated with the implanted device compared with the rate in the premarket clinical studies (9.9%).  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%.”

FDA’s Recommendations for Patients and Caregivers

FDA’s notice provides specific recommendations for patients who have had the device, and those considering it. Specifically, the FDA notice states:

Patients who are considering a Hintermann Series H3 TAR system:

    • Discuss all available treatment options for painful arthritic ankle joints with your health care provider.
    • Know there are benefits and risks associated with all joint replacement medical devices and procedures.

Patients who have a Hintermann Series H3 TAR system:

    • If the system is functioning well, and you have no new or worsening pain or symptoms, the FDA does not recommend surgery to remove it.
    • Contact your health care provider if you are experiencing any of the following:
      • any new or worsening pain or swelling,
      • inability to use your ankle or bear weight,
      • grinding or other noise, or
      • weakness around your implanted device.
    • Be aware, your health care provider may perform a physical examination of your operated ankle and obtain X-rays to evaluate it. In some instances, a CT scan may be necessary to assess if the plastic component in your Hintermann Series H3 TAR system is broken.
    • Report any problems or complications experienced with your TAR system to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Put simply, if you had this device, you should speak with a healthcare professional. You may have legal rights if you had to have the device removed. Contact us to discuss.

FDA’s Recommendations for Health Care Providers

FDA’s notices about the Hintermann ankle also gave guidance to health care providers. It said specifically:

  • Review and discuss the Recommendations for Patients and Caregivers above with your patients.
  • As part of shared decision-making, discuss the benefits and risks of all relevant treatment options for painful arthritic ankle joints with your patients.
  • When making treatment recommendations, consider that there is a higher risk of device failure with the Hintermann Series H3 TAR system compared with the rate in the premarket clinical studies.
  • Read and carefully follow the Instructions for Use for the Hintermann Series H3 TAR system.
  • Monitor patients with the Hintermann Series H3 TAR system for device problems such as loosening and fractures of the implant components of the device.
  • For suspected device problems, such as a fractured plastic (polyethylene) component, consider performing X-rays to further evaluate the device integrity.
    • Be aware that changes on X-rays can be subtle. If X-rays are negative and polyethylene fracture is still suspected, a CT scan may be needed to determine whether a plastic component fracture has occurred.
    • Be aware that the clinical presentation and the signs or symptoms of fracture in plastic materials such as polyethylene can be subtle even in a CT scan.
  • Report any problems or complications experienced by patients with Hintermann Series H3 TAR systems to the FDA.

We underscore the need to report device failures to FDA.

Contact KBA Attorneys if you had the Hintermann ankle.

This is not medical advice, of course. We’re just attorneys. If you had this device, contact us for legal advice. Speak with your surgeon or healthcare provider about your symptoms and for medical advice.