A patient has filed a lawsuit against Zimmer, saying that a faulty hip replacement device made by the company was used in his surgery and caused him injury.

New Jersey residents Frank. C. and his wife, Marie, have taken Zimmer Inc. to task over their Zimmer Versys/Anatomic II Hip System, saying that the device is defective. In Frank’s eyes, the device did not undergo sufficient testing before being sent onto the market, which put patients at risk.

Frank explains that on or around April 12, 2010, he underwent a total hip replacement of his left hip. He says that he was implanted with a Zimmer Hip system, which consisted of a Zimmer Versys cobalt chromium femoral head, an Anatomic II titanium alloy standard femoral stem, and other components.

He goes on to note that there were no complications with the surgery itself, and he was sent home on April 15, 2010. However, in November 2017, Frank says that he underwent an MRI for his kidneys, and the MRI showed a fluid collection around his left hip. Allegedly, he then had a blood test done, which showed elevated metal levels of cobalt 11.2 and chromium of 1.4.

The Zimmer hip problem lawsuit states that in January 2018, he saw an orthopedic specialist in Palm Beach Gardens, Fla. for mild pain in his left groin. The specialist reportedly reviewed the 2017 MRI, and diagnosed Frank with left hip pseudo tumor with probable trunnionosis. The specialist then reportedly recommended that Frank have a revision surgery for his left hip.

A study published in the National Center for Biotechnology Information explains that in a hip replacement system, trunnionosis is the wear of the femoral head on the femoral neck. According to the study, trunnionosis has been identified as a growing cause of hip replacement failures. 

The Zimmer Versys hip replacement failure lawsuit goes on to describe Frank’s revision hip replacement surgery that took place on June 28, 2018. Frank says that his surgeon found a large pseudotumor, metallosis, and corrosion at the trunion taper of the hip and some destruction of Frank’s abductor muscles. Frank’s hip was replaced with a different hip system – a Zimmer 36mm Longevity elevated poly liner and a 33mm Biolox Delta ceramic head.

Frank argues that in addition to the initial injury he suffered from the Versys/Anatomic II Hip System, he suffered additional complications from his revision surgery. Allegedly, he suffered severe pain, emotional distress, and reduced use of his left leg. He also states that he experienced economic damages including hospital and medical expenses, as well as lost wages. Franks says he continues to incur economic damages as a result of his revision surgery.

The Zimmer class action lawsuit asserts that the Versys/Anatomic II system is defective, because it employs two metal components that rub together, and can wear improperly on one another. This is not a new issue – an FDA panel is currently hearing about metal hip implant problems.

Allegedly, the irregular wear on the two metal pieces of Frank’s hip replacement led to the metal of the device fretting off from the components into Frank’s body. This then led the device to corrode, and caused his metallosis, or the levels of metal in Frank’s body to elevate.

The Arthritis Foundation describes the risks that may be associated with metal on metal hip replacements. 

Frank argues that the device was not subjected to enough testing by the FDA before it was released onto the market. He states that it received an approval without being subjected to significant testing because it was “substantially similar” to other devices already on the market. However, the problems with the Versys/Anatomic II Hip System existed in its predecessor, says Frank. In his eyes, the approval for the device was based on its similarity to an unsafe device.

The Zimmer Versys/Anatomic II Hip System Lawsuit is Case No. 9:20-cv-80937-RS, in the U.S. District Court for the Southern District of Florida, West Palm Beach Division.