Hip Replacement Lawsuit Claims System Failure Caused Woman To Suffer ‘Dusky Metal Disease’

Lawsuit raises concerns about safety of metal-on-metal hip replacement systems, which have been linked to high rates of failure and metal poisoning.

A Wisconsin woman has filed a hip replacement lawsuit, alleging that a Smith & Nephew metal-on-metal hip implant system caused toxic metal debris to accumulate in her body.

The complaint (PDF) was brought by Cheryl A. Miller in the U.S. District Court for the Eastern District of Wisconsin on May 28, naming Smith & Nephew Inc. as the sole defendant. 

Miller claims Smith & Nephew marketed and promoted an unapproved metal-on-metal total hip arthroplasty (THA) system for years, despite mounting evidence that similar implants were linked to elevated failure rates, metal toxicity and severe tissue damage.

Hip Replacement Device Concerns

For decades, concerns have surrounded metal joint replacement devices, particularly metal-on-metal hip implants, which can release cobalt, chromium and other metal ions into the body as components wear against one another. The resulting buildup of metal debris, a condition known as metallosis, has been associated with serious complications, including soft tissue destruction, pseudotumors and other adverse health effects.

Federal regulators began scrutinizing these risks more than a decade ago. In May 2011, the FDA directed manufacturers of metal-on-metal hip implants to conduct additional studies on the release of metal particles and their potential health consequences. The following year, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) advised recipients of metal-on-metal hip implants to undergo annual blood testing to monitor for elevated metal ion levels and signs of metallosis.

Metal-on-Metal Hip Implant Failure Allegations

According to the lawsuit, Miller received a Smith & Nephew cobalt-chrome femoral head, Synergy femoral stem and modular neck sleeve during a left hip replacement procedure performed in December 2011 at Aurora Medical Center in Grafton, Wisconsin.

More than a decade after receiving the implant, Miller allegedly began suffering complications that required revision surgery on November 19, 2024. According to the complaint, orthopedic surgeon Dr. Jesse Bauwens documented “dusky metal disease,” trunnionosis, wear of the trunnion sleeve and elevated cobalt and chromium levels in Miller’s hip joint.

The lawsuit claims those findings were caused by the failure of the implant system, which allegedly generated microscopic metal debris as its components rubbed against one another inside her body. The complaint alleges the resulting cobalt and chromium particles entered Miller’s bloodstream and surrounding tissue, causing inflammation, tissue destruction and an adverse local tissue reaction that led to device failure.

Smith & Nephew’s modular femoral head system allegedly suffered from the same design problems that plagued other metal-on-metal hip implants, including devices manufactured by DePuy, Zimmer Biomet and Wright Medical, many of which were later recalled or removed from the market.

The complaint alleges metal wear debris generated by these implants is biologically reactive and toxic to human tissue, causing cell death, inflammation and premature implant failure. It further claims Smith & Nephew knew about concerns involving metal-on-metal hip systems for years but continued promoting the products without adequately warning physicians or patients about the risks.

“Had she known that the THA device carried a risk of metal toxicity, Plaintiff would have elected to have a total hip system with traditional materials such as ceramic or polyethylene implanted in [her] body.”

— Cheryl A. Miller v. Smith & Nephew Inc.

Metal-on-Metal Hip Replacement Device Warning Claims

The lawsuit further alleges Smith & Nephew repeatedly failed to obtain FDA approval for use of the modular femoral head as part of a metal-on-metal total hip replacement system, yet continued marketing the device for that purpose. The company is accused of withholding information about failure rates, metal toxicity risks and concerns raised by regulators and joint replacement registries in Australia, New Zealand, Canada and the United Kingdom.

As early as 2012, foreign health authorities allegedly warned that certain Smith & Nephew metal-on-metal hip systems were associated with higher-than-expected revision rates and should no longer be recommended for total hip replacement surgery.

The filing also points to a series of FDA communications issued between 2011 and 2013 warning that metal-on-metal hip implants can release metal particles that damage bone and soft tissue, loosen implants and increase the likelihood of revision surgery.

Miller raises allegations of defective manufacturing, defective design, defective warning, defective due to nonconformity with representation and strict liability. She seeks compensatory and punitive damages for injuries allegedly caused by the failed implant, including pain, suffering, medical expenses and the need for revision surgery.

Hip Implant Lawsuits

As Miller’s complaint indicates, metal-on-metal hip replacement system recalls have resulted in widespread safety concerns over the past two decades, with patients reporting premature failures, metallosis and other serious complications.

In addition, researchers and regulators have examined whether metal debris released by these implants may contribute to the formation of pseudotumors and other long-term health risks.

Many of these concerns have led to large-scale product liability litigation. Nearly 12,000 DePuy ASR hip implant lawsuits were filed after those devices were withdrawn from the market in 2010. The manufacturer, Johnson & Johnson, later agreed to pay more than $2 billion to resolve the claims.

Similar allegations have also been raised in litigation involving other metal-on-metal hip systems, including the DePuy Pinnacle, Biomet Magnum and other implants.

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