The Unacceptably High Failure Rate of DePuy Knee Replacement Device

DePuy Knee Lawsuit News

DePuy Synthes has brought a new DePuy Knee Revision System to market to address some of the shortcomings of the original device

Monday, May 7, 2018 - Rushing a medical device to market under the FDA's 510(k) fast-track program can lead to disaster. Under the 510(k) program, a medical device is allowed to be brought to market without having to undergo the usual and strict FDA testing if it can be proven that the medical device is substantially similar to one already approved and on the market. Such was the case with the DePuy Knee System. The DePuy Knee Replacement System was approved for use in December 2010.

Adverse event reports filed with the FDA are close to ten times as many for the DePuy Knee Replacement System as for the nearest competitor. The Depuy Knee has been shown to be defective in approximately 5% of the 500,000 or so knee replacement procedures performed since the device was brought to market. At that rate, around 25,000 revisions surgeries will be required to replace or repair the knee replacement. In fact, so many revision surgeries are needed every year that DePuy Synthesis has brought to market a totally new and improved DePuy knee, one that addresses some of the issues that were brought to their attention by patients having to have revision surgery to replace the failed DePuy knee.

Patients with a failed DePuy Knee replacement system report they have experienced severe and persistent pain, instability when going up and down stairs, a complete lack of lateral mobility, and loosening at the point of the tibial baseplate where the device attaches to the bone resulting in bone loss. Odtmag.com writes that in an article recently published in the Journal of Knee Surgery, "nine prominent orthopedic surgeons reported that they have encountered an unusually high-rate of premature failures of the Knee System. The surgeons attributed the failures to the debonding of the tibial implant-cement interface. In other words, the surgeons discovered that the "glue" typically used to hold an implant in place does not "stick" adequately to the tibial component of the Knee System. As a result, the tibial component of the Knee System loosens and the entire knee replacement is destabilized. "In an attempt to address these issues, the new DePuy Knee Revision device offers, "metaphyseal sleeve sizes, offset adaptors, stems and fixation choices" according to "Dr. Douglas" Dennis, Orthopaedic Surgeon, Denver, CO. in an interview with www.news-medical.net.

Bringing a new DePuy knee to market is not the first time Synthes has been forced to deal with the failure of the DePuy Knee. When DePuy Synthes was faced with complaints and lawsuits pertaining to a dislodged spring coil breaking off, entering, and being left behind within the surgical site, the company announced a recall of the articulation surface component. A Class II recall is issued to alert the medical community that the device can cause temporary yet no less severe medical problems. DePuy knee replacement systems have been found to fail prematurely and patients were not warned of the risks posed by DePuy knee replacement. In 2013 Johnson & Johnson paid $2.5 billion in DePuy knee lawsuits.

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