Florida Man Files Lawsuit Over Alleged DePuy Attune Knee Replacement Failure

Published on June 15, 2018 by Sandy Liebhard

Johnson & Johnson and its DePuy Synthes subsidiary continue to face a growing number of lawsuits over the allegedly defective Attune Knee Replacement System.

One of the most recent DePuy Attune Knee lawsuits was filed on May 31^st in the U.S. District Court, Southern District of Florida, on behalf of Donald Sizemore, who received an Attune Knee during a right total knee replacement in March 2014. (Case No. 9:18-cv-80707-DMM)

He soon began experiencing severe pain and discomfort caused by, among other things, loosening of an allegedly defective tibial baseplate component. As a result of these complications, Sizemore was forced to undergo revision surgery to remove and replace the DePuy Attune Knee in May of 2014.

The complaint alleges that the Attune Knee System suffers from an unacceptably high rate of premature failures and asserts that hundreds of people have been forced to undergo risky revision surgeries due to the purportedly defective implant.

Did DePuy Launch New Tibial Baseplate to Replace Defective Component?

The complaint also asserts that DePuy recently attempted to replace the original Attune Fixed Base tibial baseplate with a new tibial baseplate, also called a tibial tray, which received FDA 510(k) clearance on June 15, 2017.

“This strategic decision to design and launch a newly designed tibial baseplate is an admission, or at the very least strong evidence, that the original ATTUNE Tibial Tray (baseplate) is defective and prone to failure,” the lawsuit states.

“However, upon information and belief, to date Defendants have not recalled the defective tibial baseplate or informed consumers and surgeons about the dangers of its use.”

In March 2016, DePuy sought clearance from the U.S. Food & Drug Administration (FDA) to market the Attune Revision Knee System, which the lawsuit claims was done in response to the growing number of failures and revision surgeries associated with the original Attune Knee system.

Studies on DePuy Attune Knee Failures

The DePuy Attune Knee System was brought to market in 2010 via the FDA’s 510(k)-clearance program. This program allows companies to sell a medical device without first subjecting it to human clinical trials, so long as the manufacturer can demonstrate that the new product is substantially equivalent to a device that was previously cleared through the agency’s standard – and more stringent – premarket approval process.

Since then, at least two studies have suggested that the Attune Knee is prone to early failure.

A June 2016 study published in the  Journal of Arthroplasty suggested that DePuy Attune Knee Replacements may be associated with a high rate of baseplate loosening and failures due to thicker cobalt-chromium tibial trays that increase the risk of bone loss.

Additional research published in the  Journal of Knee Surgery identified 15 cases of tibial loosening at the cement-implant interface among patients who had undergone revision of an Attune Knee at three hospitals. The authors of the study also identified 21 similar reports that had been logged with the FDA’s adverse event database within a two-month time period, along with numerous reports of other tibial failures in which the mechanism for failure was not specified.