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According to allegations raised in a recently filed product liability lawsuit, problems with a Depuy Attune knee replacement allegedly caused a Florida man to require revision surgery and removal of the implant only two months after it was placed in his body.
The complaint (PDF) was filed by Donald Sizemore in the U.S. District Court for the Southern District of Florida on May 31, indicating that DePuy Synthes and its parent company, Johnson & Johnson, manufactured and sold defective components, which made the knee replacement system prone to failure.
Sizemore indicates that a DePuy Attune Knee system was used during a right total knee replacement surgery in March 2014. The system included a fixed tibial insert and tibial baseplate. However, shortly after the surgery, Sizemore suffered severe pain and discomfort, leading his doctors to discovery that the problems were caused by a loosening of a defective tibial baseplate.
He underwent revision surgery in May 2014, just a little more than two months after the Attune knee was implanted.
The DePuy Synthes Attune Knee system was approved by the FDA in 2010, and has been widely used by surgeons nationwide since early 2013. Amid aggressive marketing, the knee implant was quickly adopted by the medical commonuty, with about 400,000 DePuy Attune knees sold worldwide.
Although most DePuy Attune knee replacements were implanted within the past few years, a high failure rate has already begun to surface in post-marketing adverse event reports.
By June 2017, the FDA had already received about 1,400 reports involving DePuy Attune knee failure, including at least 633 cases where individuals have already required revision surgery, according to the complaint.
“Plaintiff, like countless other knee replacement patients who were implanted with the Attune Device have been required to undergo one or more revision surgeries well before the advertised and promoted life expectancy of the Attune Device,” Sizemore’s lawsuit states. “The high failure rate of the Attune Device is greater than reasonably expected for a safe and effective medical device or implant.”
Sizemore’s claim raises allegations similar to those presented in other knee replacement lawsuits being pursued by individuals who have experienced problems with DePuy Attune implants in recent years. The primary reason for early failure is often cited as 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 review claims for individuals who have experienced complications following surgery in recent years. 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.