Wright Profemur Hip Recall Should Have Been Issued, According to Lawsuit

An Arizona man who had his Wright Profemur hip fracture suddenly, has filed a product liability lawsuit alleging that the manufacturer should have recalled the artificial hip component after it discovered that it may be prone to failure.

The Wright Profemur hip lawsuit was filed last week in the U.S. District Court of Arizona by Dale Purcell, who had the titanium modular neck of his hip replacement fracture last July while he was getting dressed for work.

A number of similar lawsuits over Wright Profemur fractures have been filed, alleging that the component is prone to fracture, break, degrade fret and ultimately fail, resulting in debilitating injuries and the need for risky hip revision surgery.

According to allegations raised in the complaint, early versions of the Wright Profemur hip implant had a femoral neck made of titanium, but the company changed the component to a chromium and cobalt alloy in 2009. However, Purcell indicates that the manufacturer failed to issue a Wright Profemur hip recall or take steps to warn the medical community or public at large about the risk of problems.

The Wright Profemur Total Hip System was approved in the United States by the FDA through the controversial 510(K) premarket approval process, which means that the company was able to begin marketing the device without rigorous testing, as it was deemed to be substantially equivalent to an existing medical device.

Although a registry for knee and hip replacements has not existed in the United States until recently, data on knee and hip implants are tracked in some other countries.

According to data in the 2009 annual report of the Australian registry, the Wright Profemur Z hip implant was identified as having a higher than anticipated revision rate, with a cumulative percent revision of 11.2% at three years.

Purcell’s implant fractured and broke near the femoral stem and left a part of the neck wedged inside that was very difficult to remove. When the implant failed, Purcell fell and was in intense pain, unable to walk. He had to undergo emergency revision surgery to remove the defective implant and regain his ability to walk.

The lawsuit seeks compensatory and punitive damages. It accuses Wright Medical of negligence, designing a defective product, failure to warn, manufacturing a defective product, and fraud.

In addition to problems with the Profemur component, a number of lawsuits have been filed over the Wright Conserve Plus Cup, which is a metal-on-metal hip replacement system, which may include the Profemur. Those complaints allege that individuals have experienced early failure of their Wright hip replacements as a result of design problems that cause microscopic shavings of metal to be released into the tissue as the cobalt-chromium metal femoral head rotates within the cobalt-chromium metal acetabular cup.

Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation ordered that all federal Wright Conserve hip replacement lawsuits will be consolidated for pretrial proceedings as part of a multidistrict litigation, or MDL. Complaints filed in U.S. Federal District Courts throughout the United States are being transferred to the Northern District of Georgia for centralized management.