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Hintermann Series H3 Total Ankle – Details about the failed ankle device and FDA safety communication

  • March 1, 2024
  • KBA Attorneys
  • No Comments

Some patients have a Total Ankle Replacement (TAR) system to treat ankle arthritis. This medical device is an alternative to fusing the bones, which reduces range of motion. Surgeons implanted these TARs in patients since at least 2009. There are two on the market and they share some common features as described next.

In general, as described in FDA’s safety communication warning of a higher risk of failure in the Hintermann Series H3 devices, “Mobile-bearing TARs consist of a metal plate in the lower leg (tibial), a mobile plastic (polyethylene) component (inlay), and a metal ankle (talar) component. They are indicated for use as a non-cemented total ankle prosthesis (“artificial joint”) and used to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic osteoarthritis, or rheumatoid arthritis.”

The Hintermann Series H3 Total Ankle Replacement (TAR) System

One total ankle system is called the Hintermann Series H3. DT MedTech LLC manufacturers this medical device. This company is located in Towson, Maryland, close to where KBA Attorneys maintains its main office.

FDA approved the product for marketing in 2019. This was the second such device. The first TAR FDA approved was the Scandinavian Total Ankle Replacement devices (STAR Ankle). FDA approved that one in 2009. That product has had issues as well.  FDA issued a Safety CommunicationExternal Link Disclaimer in 2021 concerning the higher risk of device failure related to breakage of the polyethylene (plastic) component of the STAR Ankle system.

Four years after approval, FDA issued a safety communication warning of a higher risk of failure associated with the Hintermann H3. The product is a “a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease.

Potential Preemption Issues

Because FDA approved the product, this raises important legal issues, including preemption. As we explain on our medical device page, there are two general ways medical devices like an artificial ankle, a TAR, get into patients. One is when FDA approves the device.

Through that pathway, defendants can sometimes raise a defense that precludes lawsuits from moving forward. We have discussed this preemption defense previously. This complicates how and why we usually sue medical device companies. Some companies do the right thing even when they may be able to invoke this defense, and there are legal strategies to assure compensation, so it is important to speak with an attorney familiar with medical device preemption if you had this product nad it failed.

Hintermann Series H3Products at Issue

Medical devices had a unique device identifier; a number to help track each specific one. FDA explains how to find this number here: UDI Basics | FDA. The Hintermann Series H3 devices at issue here are:

Contact Us – Potential Qualifying and Exclusion Criteria

If you had one of these devices specak with your healthcare professional. If it failed – if you had to have surgery to fix it in some way (revise it/revision surgery) or remove it, contact us today. Some exceptions, some cases we might not be able to help with, include patients who had the following situation apply to them when the surgeon implanted the device:
• Skeletal immaturity
• Bone stock inadequate to support the device including:
o Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality
o Avascular necrosis of the talus
• Active or prior deep infection in the ankle joint or adjacent bones
• Malalignment or severe deformity of involved or adjacent anatomic structures
o Hindfoot or forefoot malalignment precluding plantigrade foot
o Significant malalignment of the knee joint
o Insufficient ligament support that cannot be repaired with soft tissue stabilization

This comes from the company’s FDA submission found here: P160036B.pdf (fda.gov).