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Wright Receives Lawsuits Over Profemur Z Hip Replacement System
04/23/2012 22:56
The Australian Joint Registry stated in a 2009 study the recorded failure rate of Wright Profemur Z hip replacement system by Wright Medical Technology. Metal-to-metal him implants have been originally designed to remain functional for up to 15 years. Albeit the reports say that Wright Profemur Z carried out an 11.3% failure rate with just three years from the time it was implanted.
It has been reported that one known failure of the Wright Profemur Z hip replacement system included its potential to fret and break, causing fractures to a recipient’s hip bone. 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.
Contrary to conventional hip replacements that feature a stationary neck design, the Wright Profemur Z hip replacement offers a modular design which includes a flexible neck (“stem”). Multiple components comprise the structure of the device. Designed to be less invasive, it also adjusts itself almost accordingly to one’s leg length making it a major advancement in artificial joint technology.
Medical experts have also taken into account that the defects may have originated from the Wright Profemur Z’s innovative design.
It has been reported that its flexibility may cause the device to eventually degrade, and ultimately break. The main feature of the device had some believing that it may be the possible cause of the injuries and possible permanent damages.
Last December 2010 and January 2011, two Colorado plaintiffs filed a lawsuit against the Wright Profemur Z hip replacement system and its manufacturer, respectively. Injuries associated to the device were the involved claims.
A plaintiff reported a complaint that the device’s acetabular section was unable to come together with her pelvis. During the revision surgery, her orthopedic surgeon discovered that the device was barely attached to her pelvis.
Several experts also believe that the Wright Profemur Z’s high failure rate may have also been contributed by its release to the market with the absence of mandatory clinical trials.
The Wright Profemur Z was made available to the market after undergoing a device approval method by the United States Food and Drug Administration known as the 510 (k) process, proving its safety and efficacy as “substantially equivalent” to other devices existing in the market. The device has not gone through appropriate testing before it has been released, albeit the device has been distributed and implanted in patients.
URL References:
https://phoenix.injuryboard.com/medical-devices-and-implants/wright-profemur-z-hip-is-an-112-failure-rate-too-high.aspx
https://www.squidoo.com/wright-profemur-z-lawsuit