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A Colorado woman has filed a product liability lawsuit alleging that design defects caused her DePuy Attune knee replacement to fail prematurely, resulting in painful complications and the need for revision surgery to remove the implant.
The complaint (PDF) was filed by Regina Dibal in the U.S. District Court for the District of Colorado late last month, naming DePuy Orthopaedics and Medical Device Business Services, Inc. as defendants.
Dibala indicates that she received a DePuy Attune Knee System during a left total knee arthroplasty in April 2013. However, within only five years after the knee was implanted, Dibala began to experience severe and persistent pain, discomfort, instability and difficulty walking, the complaint indicates.
Her doctor took radiographs of the artificial knee, which revealed asceptic loosening of the implant’s tibial baseplate. As a result of the knee replacement failure, she underwent revision surgery in December 2018, at which time the implant was removed.
“The primary reason the Attune system fails is mechanical loosening,” Dibala’s lawsuit states. “The mechanical loosening is caused by a failure of the bond between the tibial baseplate at the implant cement interface.”
The DePuy Synthes Attune Knee was approved by the FDA in 2010, and has been widely used by surgeons nationwide since early 2013. Amid aggressive marketing, about 400,000 DePuy Attune knees were implanted during the first five years the device was on the market worldwide.
Although knee replacements are typically expected to last close to 20 years, and DePuy Attune implants have only been available for less than six years, a high failure rate has emerged in post-marketing adverse event reports.
By June 2017, the FDA had received about 1,400 reports involving DePuy Attune knee replacement failures, including at least 633 cases where individuals had already required revision surgery.
When the knee replacement loosens and fails, 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.
Over the coming years, the number of DePuy Attune knee lawsuits filed nationwide is expected to continue to grow, as lawyers review claims for individuals who have experienced problems in recent years. In addition, some experts have suggested that the DePuy Attune knee failure rate may increase dramatically over time, as the devices are in place longer.