A Texas man has become one of the most recent plaintiffs to file a lawsuit over DePuy Synthes’s Attune Knee System.
According to a complaint filed in the U.S. District Court, Northern District of Texas, on August 8th, plaintiff Derrick Pearson underwent right-sided total knee replacement surgery on March 7, 2016, at which time he was implanted with the DePuy Attune Knee Replacement System, including a fixed tibial insert and a fixed tibial baseplate. (Case No. 3:18-cv-02073-B)
He soon began to experience severe and persistent pain, discomfort, instability, and difficulty walking. Radiographs taken in October 2016 exhibited loosening and debonding of the tibial tray, which his doctor noted had been seen in Attune systems.
Pearson underwent knee revision surgery to remove and replace his Attune knee in May 2017, at which time his doctor found that “the tibial tray was completely loose and it was removed with hand only without any instruments. There was complete separation of the cement with the tray which is essentially the observation I have had in all the revision I have done with the series of this particular instrumentation system.”
“All of the injuries and complications suffered by Mr. Pearson were caused by the defective design, warnings, construction, and unreasonably dangerous character of the ATTUNE system that was implanted in him,” the lawsuit charges. “Had Defendants not concealed the known defects, the early failure rate, the known complications, and the unreasonable risks associated with the use of the ATTUNE system, Mr. Pearson would not have consented to the ATTUNE system being used in his total knee arthroplasty.”
The U.S. Food & Drug Administration (FDA) approved the DePuy Attune Knee System in 2010 via its 510(k)-clearance program. This program allows manufacturers to bring a medical device to market without the benefit of human clinical trials, so long as the company can demonstrate that the new product is substantially equivalent to a device that was previously cleared through the FDA’s standard – and more stringent – premarket approval process.
Two studies published since the approval of the Attune Knee System have suggested that it is prone to early failure and other complications.
These studies include a paper published in the Journal of Arthroplasty in June 2016, which 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 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 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.