A Virginia woman filed a metal hip replacement lawsuit against DePuy Orthopaedics Inc. for injuries she allegedly suffered after getting implanted with a Pinnacle hip. She alleges the injuries and complications she suffered were caused by the defective design, inadequate warnings, and other problems with the device.

Kirvin underwent a surgical procedure in 2009 to implant a Pinnacle hip. After surgery, friction and wear between the cobalt-chromium metal ions and particles were allegedly released into Kirvin’s blood and tissue and bone surrounding the hip implant.

As a result, the lawsuit said, Kirvin experienced severe pain and discomfort and inflammation in her right hip and thigh area. She also experienced pain and discomfort in her right hip when moving to and from a sitting position, and when standing. She was not also able to walk long distances and had limited range of motion, pain and discomfort.

Laboratory tests allegedly confirmed Kirvin had highly elevated cobalt and chromium levels in the blood that would likely trend upwards as a result of the metal on metal abrasion.

Due to chronic pain and discomfort and other symptoms, Kirvin underwent revision surgery in 2013 at Chesapeake Regional Medical Center in Chesapeake, Va., to replace the implant.

The Pinnacle Hip

The Pinnacle Acetabular Cup System was designed for the purpose of reconstructing human hip joints that were damaged from conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis, fracture, and other degenerative conditions.

According to the hip implant lawsuit, DePuy Orthopaedics was able to market the Pinnacle system with virtually no clinical or non-clinical trials or U.S. Food and Drug Administration review of the implant for safety and effectiveness.

The hip implant lawsuit claims that if DePuy conducted clinical trials of the Pinnacle hip before it was first released in the early 2000s, the company would have learned years sooner about the numerous problems. DePuy would have found out that use of the Pinnacle hip results in a high percentage of patients developing metallosis, biologic toxicity, and an early and high failure rate due to the release of metal particles in the patient’s surrounding tissue when the cobalt-chromium metal femoral head rotates within the cobalt-chromium metal acetabular liner.

The metal hip implant lawsuit alleges the FDA has received more than 1,300 adverse reports regarding problems associated with or attributed to the Pinnacle.

A number of government regulatory agencies have recognized the problems that are caused by metal-on-metal hip implants. For instance, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom investigated the metal-on-metal hip replacement system after it received widespread reports of tumor growth and soft tissue reactions in thousands of patients who had received the hip implants.

The Alaska Department of Health also issued a bulletin warning of the toxicity of the DePuy metal-on-metal hip implant systems. The State of Alaska recommended close medical monitoring and treatment of all patients who had received these and similar metal-on-metal hip implants.

Despite public knowledge of the issues, the hip implant lawsuit alleges that  DePuy continues to misrepresent the Pinnacle hip implant as a high quality, safe and effective product.

The hip implant lawsuit said Kirvin would not have agreed to surgery if she knew the potential complications. Her metal hip replacement lawsuit alleges that had DePuy Orthopaedics had not concealed defects, the early failure rate,  and known complications and the unreasonable risks associated with the use of the Pinnacle Device, Kirvin would not have consented to the Pinnacle hip being used in her total hip arthroplasty.

This DePuy hip lawsuit is Janice L. Kirvin v. DePuy Orthopaedics Inc., Case No, 3:14-cv-00834-K, in the U.S. District Court for the Northern District of Indiana.