DePuy Orthopaedics is facing a new Pinnacle hip implant lawsuit from a Kentucky man who is filing his claim in a growing multidistrict litigation (MDL) against the company.

The Pinnacle hip implant MDL centers its claims around allegations that the hip replacements contain a design defect that may lead to early hip implant failure and serious metal hip implant injuries.

Plaintiff Phillip A. says that he was implanted with the hip replacement device on March 5, 2007.

After the device’s implantation, however, he says that particle debris from the device caused him to suffer from severe pain, inflammation, bone and tissue loss and other injuries.

Phillip filed his Pinnacle hip implant lawsuit on Nov. 21, 2017 in the U.S. District Court for the District of Texas.

The Pinnacle hip implant lawsuit was filed on multiple counts including negligence, negligent misrepresentation, breach of implied warranty, defective design, failure to warn, fraudulent misrepresentation and others.

Pinnacle Hip Implant MDL Overview

DePuy, a division of Johnson & Johnson, is one of the largest hip replacement manufacturing companies in the world. The company sells individual hip implant parts such as acetabular cups, femoral stems, femoral heads and complete hip replacement systems.

The product at issue is DePuy’s Pinnacle Acetabular System. It was released in 2001 and is a total hip arthroplasty system designed to increase a patient’s mobility and range of motion.

However, according to the Pinnacle hip implant MDL, the hip implant system allegedly causes serious injuries such as bone loss, pain, and problems moving the affected joint.

Other serious side effects reported include the releasing of toxic levels of metal particles into a patients’ bloodstream. Metallosis, the build-up and deposit of metal debris in the body’s soft tissues, has also been said to occur.

The reasons these adverse effects and serious injuries are said to happen is because of the device’s allegedly defective nature. The Pinnacle hip system is considered a metal-on-metal (MoM) device when it is used in combination with Ultamet, a metal acetabular liner.

DePuy’s metal-on-metal hip replacement device is composed of chromium and cobalt, among other metals. The femoral head, composed of titanium with a chromium and cobalt liner, rotates within the acetabular cup.

With the implantation of these two components, the metals rub together and make contact. This can cause the release of cobalt and chromium ions into the patient’s surrounding tissue and bloodstream.

In addition to metallosis, the metal debris increases the risk of patients developing degenerative heart disease, cancer, non-cancerous tumors, swelling, pain, premature failure of the device, and inflammation.

Patients who have suffered from these adverse effects often have had to undergo revision surgery, which is often more invasive and complicated than the first.

Although approved by the U.S. Food and Drug Administration (FDA) in 2000, further allegations against DePuy report that clinical trials of the DePuy Pinnacle Hip Acetabular Cup System were not conducted.

The Pinnacle hip implant was approved through the FDA’s 510(k) process, which allows a medical device to skip certain clinical testing if a manufacturer can prove a similar device is already approved.

In this case, DePuy used its predicate product, the ASR XL Acetabular System, to approve the Pinnacle hip replacement system. The ASR XL Acetabular System was later taken off the market in 2010 for causing increased risks of hip failure.

According to the Pinnacle Hip Implant MDL, “in August 2010, defendants, in acknowledging the high failure rate of the ASR, recalled more than 93,000 ASR’s worldwide.”

“It is anticipated that defendants will at some point recall Pinnacle Devices for the same reason.”

The Pinnacle Hip Implant Lawsuit is Case No. 3:17-cv-03184-K, in the U.S. District Court for the Northern District of Texas, Dallas Division.