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According to allegations raised in a recently filed product liability lawsuit, design problems with the Consensus Total Knee System makes the implant prone to fail, which may result in the need for revision surgery after just a couple of years.
The complaint (PDF) was filed last month by Robert Best in the U.S. District Court for the Eastern District of Arkansas, indicating that Consensus Orthopedics, Inc. and up to 10 unidentified John Does, who may have been involved in the design, manufacture, sale, supply, distribution and marketing of the implants, provided an unreasonably dangerous and defective knee replacement system.
Best indicates that he underwent a right total knee replacement in March 2014, at which time the Consensus Total Knee System Replacement prosthesis was implanted in his body. Although a knee replacement is typically expected to last about two decades, only three years later the Consensus knee failed, according to the lawsuit,
On September 19, 2017, x-rays of Best’s right knee showed that the polyethylene insert component of the Consensus implant had failed, resulting in the component becoming dislodged from the tibial tray, according to the lawsuit. As a result of the knee replacement problems, Best underwent revision surgery to have the implant removed in February 2018.
“Consensus Total Knee System Replacements and its components were defectively designed in that the polyethylene tibial insert would dislodge from the tibial tray causing dangerous instability, injury, and pain,” the lawsuit states. “Additionally, the Consensus Total Knee System Replacements and its components were defectively manufactured in such a manner as to cause the tibial insert to bend, move, slip, and/or break.”
Best presents claims of strict product liability, negligence, gross negligence, and breach of warranty. He seeks both compensatory and punitive damages.
The lawsuit is one of the first over the Consensus Total Knee System. However, similar product liability claim shave been brought against the manufacturers of other knee systems introduced in recent years that featured design defects, including the DePuy Attune knee replacement, which has also been linked to tibial tray failures.
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.