Wright Hip Replacement Lawsuit Filed Over Loosened Cup with Profemur Z
A Wright Profemur hip replacement lawsuit has been filed by an Arizona woman who claims that the acetabular cup in her implant became loose just three years after receiving it.
The complaint was filed by Virginia M. Welch on October 27, in the U.S. District Court for the District of Arizona.
Welch received a Wright Profemur implant in her right hip in February 2006, but had to have it removed in November 2009 after she began suffering severe hip pain. A radiograph revealed that the acetabular cup had loosened and appeared to be rotated clockwise about 90 degrees from where it should have been.
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While a number of lawsuits have been filed over problems with Wright Profemur hip replacements in recent months, most of the complaints have focused on an alleged tendency of the femoral neck for the artificial hip to suffer catastrophic failure, shattering inside patients’ bodies.
Welch’s complaint alleges that the Wright Profemur hip was defective, and prone to crevice corrosion due to the press fit nature of the modular implant, which coupled with the progressive wear of the surface due to use of the implant, created a risk of the neck loosening from the press fit and thus failing. The complaint raises claims for failure to warn, design defect, manufacturing defect, breach of warranty and negligence.
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 (PDF), 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.
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