An Arizona woman is suing DePuy Orthopaedics and Johnson & Johnson over a failed Pinnacle Acetabular Cup System.

Plaintiff Margaret S. underwent a left hip replacement procedure in mid-January 2007. A Pinnacle metal-on-metal device with a metal liner was implanted in place of her left hip.

According to her complaint, “after the replacement surgery, friction and wear between the metal on metal parts caused large amounts of toxic cobalt-chromium metal ions and particles to be released into Plaintiff’s blood and tissue and bone surrounding the implant.”

Margaret’s doctor has recommended removal of the Pinnacle Acetabular Cup System, believing it to be the cause of her “hip pain, disability, elevated metal levels” and other symptoms.

Margaret has suffered severe pain in her left thigh and groin, in addition to functional difficulties after the implantation of the Pinnacle Acetabular Cup System.

She is scheduled to undergo hip revision surgery at the end of January 2017.

Pinnacle Acetabular Cup System Not Pre-Market Tested

Due to a loophole in FDA regulations, DePuy was “able to market the Pinnacle Device with virtually no clinical or non-clinical trials or FDA review of the implant for safety and effectiveness.”

The Pinnacle Acetabular Cup System lawsuit contends that if clinical trials had been conducted, the manufacturer would have known of the “high percentage of patients developing metallosis, biologic toxicity and an early and high failure rate due to the release of metal particles… implantation of the Pinnacle Device results in nearly immediate systemic release of high levels of toxic metal cobalt-chromium ions into every hip implant patient’s tissue and blood stream.”

This reaction occurs because the metal femoral head rotates within the metal liner. This friction causes cobalt-chromium particles to be released into the surrounding tissue where metallosis and pseudotumors can develop.

If clinical trials had been performed prior to the market release of the Pinnacle System, DePuy and Johnson & Johnson would have been aware of the problems before patients received implants, lawsuits like Margaret’s allege.

The FDA has received more than 1,300 adverse event reports in relation to the Pinnacle Acetabular Cup System.

Pinnacle System Promoted as Safe and Effective

DePuy and Johnson & Johnson are accused of marketing the Pinnacle System as a superior hip replacement device “featuring TrueGlide technology, allowing the body to create a thin film of lubrication between surfaces, which enables ‘a more fluid range of natural motion.’”

Promotional materials featured a young lady trying on tennis shoes at an athletic shoe store, accompanied by the words that the Pinnacle System was “uniquely designed to meet the demands of active patients like you – and reduce pain.”

The Pinnacle Acetabular Cup System lawsuit accuses the manufacturers of “negligently advertising and recommending the use of the Pinnacle Device despite the fact that Defendants knew or should have known of its dangerous propensities.”

If you or someone you know has received the Pinnacle Acetabular Cup System hip implant and now suffer consequences, you could be eligible for compensation through legal representation.

The DePuy Pinnacle Acetabular Cup System Lawsuit is filed within MDL No. 3:11-MD-2244-K in the U.S. District Court for the Northern District of Texas, Dallas Division.