Along with some other medical device lawsuits that have been gathering media attention, the Wright Medical Technology Profemur Hip Replacement has recently come under fire with allegations that it is prone to early failure. The Profemur hip replacement prosthesis was approved by the United States Food and Drug Administration[“FDA”] pursuant to the 510(K) process, which expedites getting the product to market. Under the 510(K) process, the manufacturer simply has to show that the device is substantially equivalent to devices already available to the public. By obtaining approval under 510(K), Wright was not required to conduct typical pre-market safety analysis. One of the big selling points of the Profemur system is the modular stem component, which can be lengthed or shortened to properly integrate with the length of the patient’s leg. There are a number of recent lawsuits however, that allege that the modular feature actually causes fractures and/or corrosion, leading to failure. Some literature suggests hip implant should last up to 15 years. A recent Austrialian study however, showed that over 11% of the Profemur implants fail within just three years.

My firm was just retained to represent an individual who underwent hip replacement surgery with implant of the Profemur system. Not long after implantation he was having significant discomfort. Physical therapy failed to correct the problem and ultimately a decision was made to remove the Profemur system. The surgeon’s report included several comments that suggest early failure of the implant. Several other cases against Wright have been filed in Illinois state court as well as federal court. And, it appears from a quick review of those matters that Wright is fighting any allegations their product was defective.