A man filed a products liability lawsuit against DePuy Orthopedics, Inc., alleging that the manufacturers sold a defective medical hip implant device.

Plaintiff Kenneth B., a resident of North Carolina, files the hip implant lawsuit in Texas federal court.

The medical device at the center of the product liability lawsuit is the Pinnacle Acetabular Cup and the Pinnacle Device Replacement System. According to his Pinnacle hip implant lawsuit, “as a result of the inadequate testing of the Pinnacle Device that was sold by the defendants and implanted in plaintiff Kenneth … plaintiff has suffered, and continues to suffer, serious bodily injury and has incurred, and continues to incur, medical expenses to treat plaintiff’s injuries and condition.”

According to the Pinnacle hip implant lawsuit, DePuy thought to market its medical device without conducting any clinical trials through the U.S. Food and Drug Administration’s 510(k) process.

The 510(k) process allows a medical device to “bypass the rigorous premarket approval process if the device is ‘substantially equivalent’ to a ‘grandfathered’ pre-MDA device…”

The process “simply requires the manufacturer to notify the FDA under section 510(k) of the MDA of its intent to market a device at least 90 days prior to the device’s introduction on the market, and to explain the device’s substantial equivalence to a pre-MDA predicate device.” The product would then have the authorization to become sold in the United States.

The Pinnacle hip implant lawsuit contends that the alleged lack of a safety and effectiveness review caused the contended defective devices’ manufacturing and sale to patients.

Many hip replacement devices use a polyethylene plastic acetabular liner. Kenneth contends, however, that DePuy’s Pinnacle Device is made from a metal acetabular liner. This metal liner and metal femoral ball rub against each other, allegedly creating serious adverse health effects and other complications.

As a result, this plaintiff among hundreds of other patients has had to undergo revision surgeries due to the allegedly failed and defective hip implant.

According to the Pinnacle hip implant lawsuit, DePuy has had to recall over 93,000 metal-on-metal ASR and ASR XL hip implants. Plaintiffs allege these implants had the same manufacturing defect as the Pinnacle ─ specifically, that the metal-on-metal parts which are made from cobalt and chromium cause a bodily adverse reaction in which the body rejects the hip implant.

Symptoms of this adverse effect are feelings of looseness, pain, dislocation, and popping or squeaking sounds. Additionally, the metal-on-metal reaction can cause metallosis, further causing soft tissues and bones to die and the accumulation of fluid around the metal hip implant.

According to the Pinnacle hip implant lawsuit, Depuy “has received an astonishing 1,300 reports associated with Pinnacle Devices.” By the end of 2008, it had received 430 reports and by the end of 2009, the company had received an increase – a skyrocketed amount of 750 reports.

The Pinnacle Hip Implant Lawsuit is Case No. 3:17-cv-01534-K, in the U.S. District Court for the Northern District of Texas.