Lawsuits Filed Over Profemur Z Hip Replacement System By Wright Medical Technology

A 2009 study conducted by the Australian Joint Registry has indicated the recorded failure rate of  Wright Profemur Z hip replacement system, an artificial hip implant manufactured by Wright Medical Technology.  Metal-to-metal him implants have been originally designed to remain functional for up to 15 years.  It has only taken three years after the implantation when failures associated to Wright Profemur Z started surfacing, reaching up to 11.3%.

The potential of the Wright Profemur Z hip replacement system to fret causing the device to fall apart while in a patient’s body leading to fractured bones has been reportedly one of the common failures that the device has been connected to.  In many cases, a revision procedure has been required in order to fix the defects and problems that may have been caused by the hip implant.

The Wright Profemur Z hip replacement promotes a flexible neck (“stem”) in its modular design, while traditional artificial hip implants utilizes a fixed-neck system. Multiple components comprise the structure of the device.  Being considered as a distinct development in artificial joint technology, it has been designed to closely replicate a patient’s leg length, promoting a minimally invasive approach.

Its ingenious design may have been the source of the malfunction, according to several medical professionals.

According to reports, the device’s tendency to degrade and eventually break may have been brought about by its flexibility.  The main feature of the device had some believing that it may be the possible cause of the injuries and possible permanent damages.

Plaintiffs from Colorado have reportedly filed a Wright Profemur Z hip replacement lawsuit against its manufacturer in December 2010, and January 2011.  Injuries associated to the device were the involved claims.

One of the Colorado plaintiffs’ allegedly reported that the hip replacement’s acetabular cup was unable to attach itself to her pelvis. The device was discovered by the performing orthopedic to be loosely connected to the plaintiff’s pelvis during her revision procedure surgery.

The lack of regulated clinical trials has been considered by some experts as a possible source of the Wright Profemur Z’s high failure rate. 

Having gone through the 510 (k) process, a device approval process by the United States Food and Drug Administration, the Wright Profemur Z was able to enter the market after having proven that its safety and efficacy is “substantially equivalent” to other similar devices already out in the market.  Being available in the market, the device has been used to patients despite the lack of conducting necessary testing to further prove its efficacy prior to its release.



URL References:
http://phoenix.injuryboard.com/medical-devices-and-implants/wright-profemur-z-hip-is-an-112-failure-rate-too-high.aspx
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