Though many of the devices have been surgically implanted, there have been several cases filed against Wright Medical Inc. claiming the Profemur Z hip implant is defective. In most cases, the implant had failed within 2 to 3 years after the surgery, despite the fact that a hip implant should last around 15 years.
In one case, X-rays revealed a problem due to a loosened acetabular cup, which appeared to have rotated 90 degrees from its original position, causing considerable pain in the affected right hip and the need for replacement surgery.
The FDA has been criticized for approving such a product with Wright Medical Technologies. The implant is a modular stem and is two pieces, not one. Theoretically, this should allow the surgeon more options for modifying the implant geometry and should yield better results, however, that is not the case.
The Australian National Joint Replacement Registry issued an annual report that said the cumulative revision rate of the Wright Profemur Hip Implant was 11.2% at just three years. Australia maintains one of the strictest medical registries, collecting data from every knee and hip implanted on the continent. This kind of data is invaluable to patients and healthcare providers, as well as medical device manufacturers. Simply, this information reveals which implants are working and which are problematic. The Wright Profemur Hip Implant is at the top of the problematic list.
Further investigation revealed that the Implant was approved by the FDA under the 510(k) protocol. This means that the FDA is allowed to approve any device that is “substantially equivalent” to a product already on the market, and does not require human trials.
Not surprisingly, devices that are approved via 510(k) protocols are the most recalled products out of any other. For example, according to a recent study published in the Archives of Internal Medicine, 113 medical devices were recalled between 2005 and 2009 and 80 had undergone 510(k) approvals. The Institute of Medicine recommended that the FDA get rid of the 510(k) process, saying it “offers patients no assurance of safety.”
Category: Wright Medical Hip Implants
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