The failure of a DePuy Pinnacle metal on metal hip replacement prosthetic motivated a patient to file a lawsuit in a federal court in Texas on March 1, 2018.

The former Pinnacle metal on metal hip replacement recipient, plaintiff Thomas U., brings his complaint against DePuy Orthopaedics Inc. and Johnson & Johnson Inc., its parent company.

The Plaintiff’s Story

According to the legal documentation, Thomas U., a citizen and resident of the state of Maryland, underwent a total hip arthroplasty (TKA) surgery for his left hip in early November 2008. He was implanted at that time with a Pinnacle metal on metal hip replacement prosthetic manufactured by DePuy Orthopaedics.

After the Pinnacle metal on metal hip replacement process was completed and an average amount of healing time passed, Thomas alleges he started to experience swelling in the joint accompanied by slight discomfort. This discomfort gradually increased to the point of severe and chronic pain, he claims.

Thomas says this pain made walking and otherwise carrying out the activities of daily life too difficult. Eventually, it became critically necessary to remove and replace the Pinnacle metal on metal hip replacement in hip revision surgery.

Slightly over eight years since being implanted with the Pinnacle metal on metal hip replacement, the plaintiff underwent this hip revision surgery on Dec. 21, 2016.

During the surgery, which was completed at Ann Arundel Medical Center in Annapolis, Md., Thomas had the former prosthetic removed and replaced with a unit comprised of ceramic and plastic parts.

Claiming harmful injuries that have caused him to suffer physically, mentally, and economically, Thomas is bringing the following claims against the defendants: Negligence; Failure to Warn; Design Defect, Manufacturing Defect; Fraud and Fraudulent Concealment; Negligent Misrepresentation; Breach of Express Warranty and Implied Warranty of Merchantability; and Violation of General Business Law.

The plaintiff is asking for compensatory damages with consideration included for medical care costs, lost income, court and attorney fees, and the pain and suffering related to his permanent injury alleged to be the direct consequence of the Pinnacle metal on metal hip replacement.

The History and Problems with the Pinnacle Hip Prosthetic Device

According to the lawsuit documentation, the Pinnacle hip prosthetic was cleared for the marketplace by the U.S. Food and Drug Administration (FDA) through the 510(k) program, which allows a medical device manufacturer to bypass clinical safety testing by piggy-backing the new device to another approved and tested device with some similarity.

While DePuy continues to claim a 99.9% success rate with this device, the lawsuit claims that the plaintiff learned of over 1,300 formal complaints made to the FDA adverse event reporting system (FAERS) regarding this product.

Most of these complaints reveal problems that Thomas alleges the company knew or should have known about. He alleges these problems could have been avoidable had adequate safety testing been done.

Metal on metal hip prosthetics where the femoral head or ball of the joint directly articulates with a metal acetabular liner have been known to shed metal debris due to friction into the surrounding tissues and blood stream.

This process has been linked to the development of pseudotumors, bone loss and tissue death, as well as fracturing and dislocation. In extreme cases, metal blood poisoning has contributed to heart disease and cancer.

The Pinnacle Metal on Metal Hip Replacement Lawsuit is Case No. 3:18-cv-00485-K in U.S. District Court for the Northern District of Texas, Dallas Division.