Biomet Signature Vanguard Knee Replacement Lawsuit Alleges Pegs in Regenerex Patella Sheared, Broke

Surgeons discovered broken pegs inside the plaintiff’s knee during revision surgery, years after a Biomet patella recall was issued.

A New Jersey man has filed a Biomet knee implant lawsuit, alleging that defective components in the device failed and caused such severe pain that he lost consciousness.

The complaint (PDF) was brought by Shawn Hecker and his wife in the U.S. District Court for the District of New Jersey on May 2, naming  Zimmer Biomet Holdings, Inc. and several subsidiaries as defendants.

The Biomet Signature Vanguard total knee system is a modular implant used in total knee arthroplasty to replace damaged bone and cartilage in the knee joint. The system includes a femoral component, tibial baseplate and a patella button, also known as the kneecap, that helps restore joint function and stability. 

In Hecker’s case, the Regenerex patella, which features three pegs meant to anchor the kneecap component to the bone, allegedly failed when the pegs sheared off, resulting in instability, pain and mechanical failure of the implant.

Zimmer Biomet Recall 

According to the lawsuit, Zimmer Biomet recalled the Regenerex three-peg patella on April 25, 2017, after reports of post-operative failures linked to peg shear. The recall indicated that the peg fractures could lead to loosening of the kneecap component, requiring revision surgery.

Despite the recall, Hecker’s complaint alleges that the company continued to market the device without adequately warning patients or surgeons about the risks. He claims Zimmer Biomet failed to issue timely post-sale warnings and used misleading marketing materials that understated the risk of patella failure, ultimately contributing to the severity of his injuries.

According to the lawsuit, Hecker underwent a total left knee replacement on June 28, 2016, during which he was implanted with a Biomet Signature Vanguard total knee system and a 31 mm three-peg Regenerex patella to serve as the artificial kneecap. The surgery was performed at Millennium Surgical Center in Cherry Hill, New Jersey.

Following the procedure, Hecker began experiencing persistent problems with his left knee, including unexpected instability, swelling and severe pain. He claims the joint would occasionally give out without warning, interfering with daily activities and mobility. In May 2023, the pain became so extreme that he lost consciousness and was rushed to Inspira Mullica Hill Hospital for treatment.

By December 2023, Hecker underwent revision surgery to replace the damaged components. During the operation, surgeons discovered that the patellar implant had come loose and that the three pegs had sheared off inside his knee. 

According to the complaint, complications from the failed implant ultimately required full removal of the device and led to major disruptions in Hecker’s life and livelihood.

“The patellar implant was found to be loose and the pegs were broken. All the implants were removed,” the lawsuit states. “Due to the defective patellar implant, Mr. Hecker was forced into early retirement and suffered significant loss of past earnings and future earning capacity.”

Hecker and his wife are pursuing claims against Zimmer Biomet for negligence, strict product liability, failure to warn, breach of implied warranty of fitness, and loss of consortium. The complaint alleges the defendants knew or should have known about the risk of peg fractures in the Regenerex patella, yet continued to market the device without adequate testing, warnings or timely corrective actions.