A Colorado woman has filed a product liability lawsuit against the makers of the Wright Profemur-Z Total Hip System after the Wright Conserve Plus cup used in the hip replacement system failed to properly attach to her hip, leaving it loose in her body.
The Wright Profemur Z hip lawsuit was filed by Janet Pommrehn on January 26 in the U.S. District Court for the District of Colorado. The lawsuit names Wright Medical Technology, Inc. and Wright Medical Group, Inc. as defendants.
According to the complaint, Pommrehn received a Wright Profemur-Z Total Hip System in her left hip in April 2008 as part of total left hip replacement. Part of the Wright hip implant was an acetabular cup called the Wright Conserve Plus. The cup was supposed to fuse with bone over time, which would lodge it firmly in place. However, the plaintiff alleges the cup failed to fuse as a result of design defects.
As a result of the Wright Profemur Z hip replacement problems, Pommrehn experienced intense pain and eventually required hip revision surgery. At that time, it was discovered that the Wright Conserve Cup was loose inside her hip, barely connected by fibrous tissue, the lawsuit claims.
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 just had to show that it was substantially equivalent to an existing medical device to get it on the market.
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 (PDF), the Wright Profemur Z hip was identified as having a higher than anticipated revision rate, with a cumulative percent revision of 11.2% at three years.
A number of other Wright Profemur hip replacement lawsuits have been filed on behalf of individuals who have experienced problems. Some complaints involve situations where the femoral neck of the Wright Profemur implant broke or fractured during normal use, resulting in severe pain and the need for revision surgery to replace the Wright Profemur hip system.