A Minnesota woman who suffered from large amounts of toxic metal particles released into her system following hip implant surgery is suing Pinnacle hip implant manufacturer DePuy Orthopaedics and its parent company, Johnson & Johnson, for concealing known defects and risks associated with the device.

Cleva J. of Saint Paul, Minn., underwent a total hip arthroplasty in February 2008. Her surgeon implanted a Pinnacle device with an Ultamet liner in place of her left hip.

After the surgery, friction and wear between the cobalt-chromium metal head and liner caused large amounts of toxic metal ions and cobalt-chromium particles to be released into Cleva’s blood, tissue and bone surrounding the implants, according to her DePuy hip lawsuit.

The metal caused Cleva to experience chronic and severe pain and discomfort, and inflammation in and around the implant, requiring her to undergo revision surgery to replace the left hip implant in April 2014.

According to her DePuy hip lawsuit, had the defendants been forthcoming about the DePuy metal hip implant’s early failure rate, the known complications and the unreasonable risks associated with it, Cleva would not have consented to the Pinnacle device being used in her total hip arthroplasty.

Pinnacle Hip Implant History

The Pinnacle hip implant was designed, developed, and sold to be used in hip joints damaged or diseased due to fracture, osteoarthritis, rheumatoid arthritis, and vascular necrosis, according to the hip implant lawsuit. It is surgically fastened to human bone with surgical screws.

Johnson & Johnson agreed to pay $2.5 billion to settle some 8,000 hip implant lawsuits filed by patients who had risky revision surgery to replace the company’s metal-on-metal hip implants, which failed at higher rates than traditional hip implants. More patients are expected to undergo revision surgery for the implants in the future.

Cleva’s DePuy hip lawsuit alleges that over 1,300 adverse reports have been submitted to the U.S. Food and Drug Administration (FDA) regarding complications or failure of the Pinnacle devices. Complaints include reports of metallosis, biologic toxicity and high failure rate.

The Pinnacle causes toxic metal ions to leak into recipients’ tissue and bloodstream, Cleva alleges. Moreover, she alleges DePuy and Johnson & Johnson are aware that the problem results in metallosis, tissue death, bone erosion and development of tumors.

In the Johnson & Johnson case, 93,000 people worldwide – about 12,000 in the United States – received the ASR XL Acetabular hip implant or the ASR hip resurfacing system implant. These implants were recalled by DePuy Orthopaedics, a Johnson & Johnson subsidiary, in 2010.

Thousands of patients who had hips replaced with metal-on-metal devices have experienced high ion concentrations of cobalt and chromium and tissue reactions. The devices fail at higher rates than traditional implants with plastic bearings, according to the website Modern Healthcare.

A medical expert specializing in adult reconstruction and joint replacement told Modern Medicine that problems caused by implants typically fall into three categories: those needing revision surgery (which costs about $100,000); those not symptomatic or suffering any pain, but MRIs indicate that they have adverse tissue reactions and elevated metal ion levels (they may also require revision surgery); and those with elevated ion levels who need to be monitored.

Minnesota is where some 2,000 of 4,000 defective hip implant lawsuits have been consolidated as part of a multidistrict litigation. Bellwether trials, intended to see how juries may rule on similar evidence and testimony, are scheduled to begin this summer.