In the past several months, at last two lawsuits have been filed alleging the Wright Profemur Hip Implants fail within just a few years of implantation. One of the lawsuits, filed in the U.S. on August 17, alleges that a Wright Profemur Hip Implant failed after the femoral neck of the device broke. A Canadian Class Action lawsuit filed earlier this month charges that Wright Medical and other defendants knew a high number of their Profemur Z Stems were failing and harming patients, but failed to disclose or warn patients about the significant risks posed by the devices.
The Wright Profemur Hip Implant was approved by the U.S. Food & Drug Administration (FDA) under the agency’s 510(k) protocols. This type of approval is allowed for a device that is “substantially equivalent” to a product already on the market, and does not require human trials. Unfortunately, medical devices approved via 510(k) protocols tend to be recalled more frequently than other products, according to recent research. For instance, a study published this summer in the Archives of Internal Medicine found that of 113 medical devices recalled between 2005 and 2009, 80 had undergone 510(k) approvals. In August, the Institute of Medicine recommended that the FDA do away with the 510(k) process after finding it “offers patients no assurance of safety.”
Some recent data does suggest the Wright Profemur Hip Implant often fail earlier than expected. According to the 2009 annual report issued by the Australian National Joint Replacement Registry, the Wright Profemur Hip Implant had a cumulative revision rate of 11.2% at three years. Ideally, a hip implant should last around 15 years.
According to the lawsuit filed by Michigan resident Terrance Allore and his wife, Rebecca, Terrance received the Wright Profemur Hip Implant in 2008. In November 2010, the femoral neck of his implant broke, causing severe problems. Allore was forced to undergo revision surgery to replace his hip implant. The lawsuit accuses the defendants of defective manufacturing, defective design, failure to warn, misrepresentation, negligence, breach of warranty, and fraud. Alloreâ€™s wife is also suing for loss of consortium.
Ken Taylor and Judy Rowter, both of Nova Scotia, are lead plaintiffs in the Canadian Wright Profemur Hip Implant lawsuits. According to the complaint, Taylor underwent a left total hip arthroplasty in June 2007, and was implanted with the Profemur Hip Implant System. On September 3, 2009, he underwent revision surgery after the neck of his left femoral Profemur Hip Implant fractured. At that time, Taylor received a Wright Perfecta Femoral Stem and a Wright Ceramic Femoral Head. Unfortunately, Taylor’s problems did not end there, according to the lawsuit. In February 2010, he underwent further revision surgery and bone graft to his left hip prosthesis as bone was not growing around his previous prosthesis.
The Canadian lawsuit was filed on behalf of a class of all Canadian residents who were implanted with a Wright Profemur Hip Implant System since 2001.
Rowter was implanted with the Wright Profemur Hip Implant system in January 2007. According to the complaint, she was informed by her surgeon in March 2010 that she should discontinue working due to numerous reports concerning the risk of fracture and susceptibility to personal injury resulting from such a fracture of the Profemur Long Neck component of the Profemur Hip Implant System. Rowter followed her physicianâ€™s advice, and remains concerned about the possibility of injury and potential necessity of revision surgery as a result of her Profemur Hip Implant System, the lawsuit says.