A North Carolina woman has filed a DePuy Pinnacle hip implant lawsuit against the manufacturers of her hip implant citing injuries and damages.

Plaintiff Patrisha N. underwent a total right hip arthroplasty with the DePuy Pinnacle device in March 2008.

She claims that over time, because of corrosion and friction wear, small amounts of toxic cobalt-chromium metal debris were released into her bloodstream and surrounding tissue around her hip implant.

According to her DePuy Pinnacle hip implant lawsuit, Patrisha says she has experienced severe pain, discomfort and inflammation around the implant.

On Oct. 7, 2016, Patrisha underwent revision surgery at the Novant Health Charlotte Orthopedic Hospital to replace the DePuy Pinnacle hip implant that had failed.

Patrisha claims that had she known about the severe complications that many other patients cite regarding the Pinnacle hip implant system, she would have never opted to use it.

The DePuy Pinnacle hip implant system has been marketed to the medical community and potential patients for those who have damaged hip joints due to fracture, osteoarthritis, rheumatoid arthritis and vascular necrosis.

DePuy also said that the Pinnacle device is the best surgical option and that it “recreates the natural ball-and-socket joint of your hip, increasing stability and range of motion.”

But according to this DePuy Pinnacle hip implant lawsuit, over 1,300 adverse reports regarding device failure have been submitted to the U.S. Food and Drug Administration.

The plaintiff in this DePuy Pinnacle hip implant lawsuit believes that the device manufacturer was aware that their hip implant devices have a high failure rate and can result in metallosis, or metal poisoning.

She alleges that DePuy knew that particulate debris from their devices can cause severe inflammation, pain, and tissue and bone loss, as well as other problems.

Patrisha alleges that the Pinnacle device underwent a type of FDA approval that is less rigorous than other types of approval. This procedure is called the 510(k) approval process, and it relies on the previous approval of other similar devices for the new device’s market approval.

After the 501(k) approval, the device is ready to be sold in the United States. When it comes to the approval of the Pinnacle, according to the DePuy plaintiff, DePuy was able to sell this device without clinical or pre-clinical trials.

The plaintiff is bringing forth claims of negligence, failure to warn, manufacturing defect, design defect, negligent misrepresentation, breach of express warranty, breach of implied warranty, and fraud.

This DePuy Pinnacle Hip Implant Lawsuit is Case No. 3:17-cv-00772-K in the United States District Court of the Northern District of Texas, Dallas Division.