A product liability lawsuit was recently filed against the maker of the Wright Profemur hip replacement. According to the lawsuit, Terrance Allore’s hip replacement device failed in less than three years following implantation.
The lawsuit was filed by Allore and his wife, Rebecca, last month in the U.S. District court for the Eastern District of Michigan. The femoral neck of Allore’s Wright Profemur hip device broke, which caused what was described as a catastrophic failure, resulting in mandatory additional surgery to replace the broken device, so-called revision surgery. The lawsuit indicates that Wright Medical Group, Wright Medical Technology, and Wright Medical Europe as defendants.
The lawsuit also explains that Allore received the Wright Profemur Total Hip System in January 2008; the device broke in November 2010. According to the complaint, the Wright Profemur hip devices do not meet established performance standards, are defective, can cause adverse reactions in patients implanted with the devices. The complaint accuses the devices makers of “defective manufacturing, defective design, failure to warn, misrepresentation, negligence, breach of warranty, and fraud.” Allore’s wife is suing for loss of consortium.
Approved in the U.S. by the U.S. Food and Drug Administration (FDA) via the 510(K) fast-tracked premarket approval process, the Wright Profemur Total Hip System made it to market without having to undergo the more scrupulous testing mandated for new devices. The 510(K) enables device makers to fast-track approvals for those devices that are considered substantially similar to a previously approved device.
Data derived from the 2009 annual report of the Australian joint replacement registry, the Wright Profemur hip implant reportedly experiences a higher-than-expected revision rate, which means that the device fails earlier than usual, and patients are forced to undergo painful and complex revision surgery. The cumulative percent revision rate at three years was 11.2%.
While hip implants devices are not expected to last a lifetime, they are typically constructed to last for approximately 20 years.
Meanwhile, more patients nationwide have filed lawsuits against Wright, including a proposed class action that was filed earlier this month against Wright Medical Group, Inc. and some of its subsidiaries in Canada. The proposed class action was filed on behalf of all Canadian residents implanted with the defective Wright Profemur Hip Implant System since 2001.
The lawsuits cite issues with the Wright Profemur’s femoral neck breaking or fracturing during normal use. Breakage or fracture can lead to significant pain and the need for revision surgery to replace the defective Wright Profemur system.