A California woman is bringing a hip replacement failure lawsuit against DePuy Orthopaedics, claiming the company failed to warn her about the risks associated with its Pinnacle hip implant.

Plaintiff Sandi O. says she has been implanted with Pinnacle devices in both her hips.

She claims she underwent arthroplasty surgery in her right hip in October 2001 and in her left hip in September 2010. Both implants included a metal liner, she says.

Following those surgeries, Sandi says, she suffered severe pain and discomfort. She claims she had to undergo revision surgery for her right hip in April 2016.

Hip Replacement Failure Lawsuit Challenges Metal-on-Metal Design

Sandi’s hip replacement failure lawsuit says the Pinnacle system consists of two component parts: a liner and an acetabular cup. The cup is made of titanium metal on its outer surface. Liners used with this cup can be made of one of three materials: ceramic, polyethylene plastic or cobalt-chromium metal.

The metal liner is what Sandi says she was implanted with, and it’s the design aspect of the Pinnacle system that she now says is defective.

Sandi says use of this liner results in metal surfaces rubbing against each other under the full weight of the human body, creating metallic debris that is released into the surrounding tissue and the patient’s bloodstream.

Sandi claims this design results in an excessively high number of reports of metallosis, or metal poisoning, associated with Pinnacle implants.

Metallosis can lead to infection, inflammation, and the formation of growths called pseudotumors, she alleges. She says these conditions can cause severe pain and discomfort, lack of mobility, and death of the surrounding bone and other tissue.

More than one regulatory body has taken action to address these possible complications, Sandi says. She reports the British Medicines and Healthcare Products Regulatory Agency conducted an investigation after receiving several reports of adverse reactions in patients who received metal-on-metal implants.

She also says the Alaska Department of Health issued a warning about the toxicity that metal-on-metal hip replacements can cause.

Manufacturer DePuy Orthopaedics knew about these problems with the Pinnacle implant system, Sandi says. Even so, she claims, DePuy continued to market the Pinnacle system, without issuing a warning to the medical community or to patients about the potential complications.

In particular, DePuy has marketed this system to physically active patients, touting it as a longer-lasting, high-performance option that allows active patients to continue being active.

Promotional materials for the Pinnacle system depict patients stretching, playing tennis and riding a stationary bike, according to Sandi.

In her hip replacement failure lawsuit, Sandi attributes her complications to the “defective design, warnings, construction and unreasonably dangerous character” of the Pinnacle implants she received.

She says that had she known the Pinnacle implants could cause symptoms like what she experienced, she would not have chosen to use them.

Sandi argues that any applicable statute of limitations should be tolled because of the defendants’ “knowing and active concealment and denial of the facts.”

Her hip replacement failure lawsuit raises claims for defective design, defective manufacture, failure to warn, negligence, negligence per se, negligent misrepresentation, fraudulent concealment, breaches of express and implied warranties, and fraud.

She seeks an award of damages including punitive damages to deter similar conduct in the future, plus an award of attorney’s fees and court costs.

The Hip Replacement Failure Lawsuit is Case No. 3:16-cv-02416, and is part of the DePuy Pinnacle MDL In Re: DePuy Orthopaedics Pinnacle Device Implant Product Liability Litigation, MDL No. 2244, in the U.S. District Court for the District of Texas, Dallas Division.