A resident of Missouri has filed a knee replacement lawsuit that accuses DePuy Synthes of marketing unreasonably dangerous and defective implants
According to complaint filed in the U.S. District Court, Western District of Missouri, on September 4th, David Love received the DePuy Attune Knee System, including a fixed tibial insert and a fixed tibial baseplate, in December 2015. (Case No. 4:18-cv-00695-BP)
Shortly after the procedure, Love began to experience severe and persistent pain, discomfort, instability, popping and clicking of his device, and difficulty ambulating, all of which the lawsuit alleges were caused a defective tibial baseplate and other device components.
Love was forced to undergo revision surgery in December 2017 to replace the Attune device. The surgeon performing the procedure diagnosed Love with a “Failed tibial component” and described that component as being “grossly loose.”
The complaint further alleges that thousands of patients have experienced similar DePuy Attune Knee failures and have been forced to undergo revision surgery within just a few years of surgery. The lawsuit further asserts that DePuy Synthes was aware that the implants were defective and prone to premature failure, yet continued to market the devices as safe and effective for use in total knee replacements.
“Upon information and belief, Defendants downplayed the health risks associated with the ATTUNE Device through promotional literature and communications with orthopedic surgeons,” the complaint alleges. “Defendants deceived doctors, including Plaintiff’s surgeons, and potential users of the ATTUNE Device by relaying positive information, while concealing the nature and extent of the known adverse and serious health effects of the ATTUNE.”
The DePuy Attune Knee System was granted regulatory clearance through the U.S. Food & Drug Administration’s (FDA) 510(K) program in 2010. This program does not require a new medical device to undergo human testing if the manufacturer can show that the device is “substantially equivalent” to an existing product that had already been cleared through the agency’s more stringent pre-market approval process.
As of June 2017, the FDA had received 1,400 reports of failures for the Attune Knee System, including 633 that resulted in revision surgeries. By comparison, a competitor’s product called the Persona knee replacement system had 183 reports of failures with 64 resulting in revision surgeries.
Two studies published since the Attune Knee System’s 510(K) clearance have suggested that the implants are vulnerable to premature failure.
In June 2016, a paper published in the Journal of Arthroplasty reported that DePuy Attune Knee Replacements were associated with a high rate of baseplate loosening and failures due to thicker cobalt-chromium tibial trays that increase the risk of bone loss.
A second study that appeared 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 paper 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