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According to allegations raised in a product liability lawsuit filed against Johnson & Johnson and it’s DePuy Synthes subsidiary, problems with a DePuy Attune knee replacement caused a Louisiana man to require revision surgery after early failure of the components due to tibial loosening.
The complaint (PDF) was filed by Rocky Thompson in the U.S. District Court for the Middle District of Louisiana on September 26, alleging that the widely used DePuy Attune Knee is defectively designed and unreasonably dangerous.
Thompson indicates that he underwent a knee replacement in January 2015, at which time a DePuy Attune system was used, including a fixed tibial insert and fixed tibial baseplate. Within a few years, persistent pain and instability resulted in the need for revision surgery to remove the DePuy Attune knee and replace it wit a new artificial knee, due to lack of bond and failure at the tibial baseplate-cement interface.
The DePuy Synthes Attune Knee system was approved by the FDA in 2010, and placed on the market in March 2013. Amid aggressive marketing, the system quickly became widely used in the knee replacement market, with about 400,000 DePuy Attune knees sold worldwide.
“Thousands of patients, like Plaintiff Rocky Thompson, have been, and/or will be, required to undergo extensive revision surgery to remove and replace defective Attune Devices. These revision surgeries have been necessitated, in part, by severe pain, swelling, and instability in the knee and leg caused by loosening of Attune’s tibial baseplate component that results from debonding at the baseplate-cement interface,” the lawsuit filed by Thompson states. “Patients implanted with Attune Devices have also experienced fractures, infection, soft tissue injury and permanent damage to bones and nerves following revision surgery.”
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.
Thompson’s lawsuit indicates 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 lawsuit indicates 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.
The lawsuit also notes that this loosening can often be detected and diagnosed using radiographic imaging. These imaging tests can find the loosening by looking for one or more radiolucent lines around the contours of the implant.
The case is believed to be the first DePuy Attune lawsuit, but the size and scope of the litigation is expected to increase over the coming months, as knee replacement lawyers are continuing to review and investigate cases on behalf of individuals nationwide. In addition, many experts have suggested that the failure rate for DePuy Attune knees may increase dramatically over time.
Thompson presents product liability claims of design defect, failure to warn, construction defect, and breach of warranty.