Biomet Phoenix Ankle Nail Lawsuit Alleges System Failed, Fractured Due to Defects

Georgia man claims the manufacturer knew of fracture risks linked to the Biomet Phoenix Ankle Nail system, but failed to warn patients.

A product liability lawsuit has been filed against Biomet, claiming the company’s Phoenix Ankle Arthrodesis Nail System fractured due to a defective design, resulting in the need for revision surgery.

The complaint (PDF) was initially brought by Mike and Deborah McCoy in the Superior Court of Hall County on April 1, naming Zimmer Biomet Holdings, Biomet, Inc., Biomet Trauma, LLC and Zimmer, Inc., as defendants. However, at the request of the manufacturers, the case was recently removed to the U.S. District Court for the Northern District of Georgia on May 9.

The Biomet Phoenix Ankle Arthrodesis Nail System is a surgical implant introduced in 2018, which is used to stabilize the ankle and hindfoot during fusion procedures, often performed to treat severe arthritis, flatfoot deformities or post-traumatic ankle conditions. The system involves inserting a large intramedullary nail into the tibia and heel bone to promote bone fusion and restore alignment. 

However, lawsuits now allege that the Phoenix Ankle Nail is prone to premature fracture due to design and manufacturing defects. When the implant fails, patients may experience severe ankle pain, swelling and mobility loss. In many cases, this results in the need for complex revision surgery to remove broken hardware and repair damage to the surrounding bone and tissue.

Plaintiffs further claim that Zimmer Biomet knew about the risk of fracture incidents, some reported to the FDA as early as 2019, but failed to issue adequate warnings to doctors or patients, exposing users to serious and avoidable health complications.

According to the lawsuit, McCoy was diagnosed with right ankle arthritis, hindfoot valgus and a flatfoot deformity when he underwent a tibiotalocalcaneal arthrodesis procedure in April 2022. As part of the surgery, his Achilles tendon was lengthened, and a Biomet Phoenix Ankle Arthrodesis Nail System was implanted, including an 11 mm intramedullary nail and a 300 mm screw.

In May 2023, after dealing with excruciating pain and swelling in his right ankle for months, McCoy underwent a revision procedure by his doctor, who discovered that the nail system had failed and fractured.

The lawsuit indicates that the fractures occurred due to the system’s defective design, noting that the Phoenix ankle system was cleared through the U.S. Food and Drug Administration (FDA) 501(k) fact-track system, which only requires a device be “substantially equivalent” to a medical device already on the market to gain approval.

“Upon information and belief, between 2019 and 2023, more than 8 instances of Nail System fracture were reported to Biomet and the FDA, Biomet had actual knowledge that Nail System was prone to fracture and failure,” the lawsuit states. “Defendants were negligent in failing to sufficiently warn Plaintiff or his medical providers of the potential for failure of the Device due to the aforementioned defects.”

The lawsuit indicates McCoy suffered permanent injuries and deformity, and presents claims of product liability, breach of warranty, and loss of consortium. The lawsuit seeks compensatory damages.