The Malfunctioning DePuy Knee System Was Untested

DePuy Knee Lawsuit News

The DePuy Knee skipped the FDA's usual product testing and went straight to market

Thursday, June 7, 2018 - When a company's scientists and inventors produce a medical device that might benefit a large segment of the population it is only natural to want to get the product out the marketplace as quickly as possible. FDA approval, however, of new and unproven medical devices is expensive, time-consuming and does not come easy. The FDA prides itself on making their errors on the side of being too cautious in order to protect the public and to reinforce their reputation as honest, independent consumer watchdogs. New medical devices may have the potential to do serious harm and even cause death to a patient if the device has unforeseen, adverse side effects or if the device simply malfunctions. Human testing on a small segment of the population is required and should be monitored and analyzed to see if the device works as advertised. For the most part, the FDA does stellar work in making sure that medical devices are what their companies say they are. Once in a while, however, a faulty medical device like the DePuy knee replacement system slips through, is surgically implanted into hundreds of thousands of people, and then malfunctions causing serious injuries and deaths.

The FDA, rushed the DePuy knee to market using the 501 (k) fast-track program and circumvented the usual testing requirements. The 501 program allows for approval of a medical device if it can be proven that it is substantially the same as another already tested device on the market. According to the FDA's website, "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution."

Although the DePuy knee is 99% similar to other artificial knees currently on the market, one major component changed that escaped the awareness of FDA officials. Thousands of adverse event reports have been filed with the FDA stating that the DePuy knee device comes loose when the glue that cements the knee to the tibia (shin bone) fails. When the cement loosens, the lower leg and foot are free to shift and twist from side to side. The movement of the metal device on bone causes chafing and rapid deterioration of the tibia as well as severe pain.

It is not hard to imagine the types of catastrophic falls that have occurred when the foot does not show up where the walker intended it to be. Falling down a flight of stairs or the inability to step up to a curb and tripping are the usual catastrophes that happen and cause injuries and deaths.

It is plain to see, that if the DePuy knee replacement device had been thoroughly FDA tested in the first place, none of this would have happened. Studies show that ten times as many Depuy knees fail as do their leading competitor, which has led to thousands of DePuy knee lawsuits.

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