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A lawsuit filed this month against DePuy Orthopaedics and Johnson & Johnson alleges that the DePuy Attune knee replacement system is defective and prone to failure, causing a Mississippi woman to require revision surgery less than two years after receiving the knee implant.
The complaint (PDF) was filed by Joyce Rogers in the U.S. District Court for the Southern District of Mississippi, indicating that the manufacturers allowed a dangerous device to be implanted in her body and in thousands of other individuals nationwide.
A DePuy Synthe Attune knee implant was used during a surgery Rogers underwent in February 2015. According to the lawsuit, her knee implant failed in November 2016, and had to be removed during a revision surgery procedure.
Rogers alleges that DePuy and Johnson & Johnson knew, or should have known, that there were problems with the design of the knee replacement system, yet continued to market and sell the components anyway, putting Rogers and others at risk.
“Recipients of the Attune Devices have been required to undergo revision surgeries well before the estimated life expectancy of the Attune Devices and at a much higher rate than should reasonably be expected for devices of this kind,” Rogers’ lawsuit states. “Despite knowledge that the Attune Devices were defective and resulted in the aforementioned failures and accompanying complications. Defendants continue to aggressively market and sell the defective Attune Devices, all the while maintaining that they are safe and effective for use in total knee replacement.”
The DePuy Synthes Attune Knee system was approved by the FDA in 2010, and was widely used by surgeons nationwide by early 2013. Amid aggressive marketing, the system was quickly adopted, with about 400,000 DePuy Attune knees sold worldwide.
Although most DePuy Attune knee replacements were implanted within the past few years, a high rate of problems has begun to surface in post-marketing adverse event reports.
As of June 2017, the FDA has already about 1,400 reports involving failure with DePuy Attune knee replacements, including at least 633 cases where individuals have already required revision surgery, according to the complaint.
In a study published earlier this year in the Journal of Knee Surgery, researchers noted a spike in DePuy Attune knee tibial loosening and failures, raising concerns about problems at the implant-cement interface.
Roger’s claim and other similar DePuy Attune lawsuits filed in courts nationwide each raise similar allegations, indicating that the primary reason for the problems is mechanical loosening, which is caused by the failure of the bond between the tibial baseplate and the implant-cement surface. The lawsuits indicate that when the loosening occurs, the artificial knee can detach from the existing bone, resulting in failure.
When the knee replacement loosens, it can cause pain and wear away the bone. This can lead to restricted physical movement and severe pain, which continues until the pain becomes unbearable, or the device fails, resulting in a loss of knee function. At this time is when most decide to undergo revision surgery to have the implant removed.
Over the coming months, the number of DePuy Attune cases is expected to continue to grow as knee replacement lawyers continue to review and investigate potential cases on behalf of individuals who experienced complications, as most individuals are not aware of the specific model used during their surgery. In addition, many experts have suggested that the DePuy Attune knee failure rate may increase dramatically over time, as the devices are in place longer.