Lawsuits are being filed over the DePuy Attune Knee System. David Love received the DePuy Attune Knee System, including a fixed tibial insert and a fixed tibial baseplate, in December 2015. He filed a complaint in the U.S. District Court, Western District of Missouri, on September 4th. (Case No. 4:18-cv-00695-BP)
After the procedure, Love experienced severe and persistent pain, discomfort and instability of his device, and difficulty ambulating, all of which the lawsuit alleges were caused a defective tibial baseplate. Love was forced to undergo revision surgery in December 2017 to replace the Attune device. The surgeon diagnosed Love with a “Failed tibial component” and described that component as being “grossly loose.” The lawsuit claims DePuy knew, or should have known, that the Attune Knee System medical device was prone to fail. They claim that the defendants designed and launched a new baseplate for the device and argue that defendants acknowledge the defective and unsafe nature of the original design.
“However, defendants have not recalled the defective Attune, nor the defective tibial baseplate components, or informed consumers and surgeons about the dangers of its use,” the lawsuit states.
Similarly, in September 2017, an Alabama law firm filed the first lawsuit alleging the premature failure of the DePuy Attune Knee System. In October 2017, Joyce Rogers sued in the U.S. District Court for the Southern District of Mississippi for damages and future compensation relating to the Attune Knee System. Rogers’ lawsuit claimed the device was defective and caused severe pain, swelling, and instability in the knee and leg that resulted from loosening of the Attune Knee System tibial baseplate component, due to debonding of the baseplate-cement interface. Rogers underwent extensive revision surgery to replace the system.
According to the lawsuit, the revision surgery resulted in a failure to bond, worn out components, fracture, the shedding of metal debris and the implant and bone detaching from one another. The lawsuit also alleges that DePuy marketed the Attune Knee System as a safe and effective knee replacement despite the high failure rate and the large number of revision surgeries that took place, that they failed to warn healthcare providers of its complications, and that they failed to test the implant. Rogers claims in the lawsuit that DePuy unlawfully and knowingly concealed information about the Attune Knee System failures even though they were under an obligation to do so. The plaintiffs seek compensatory and punitive damages. They accuse the defendants of negligence, inadequately warning, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud, violating the Missouri Merchandising Practices Act and loss of consortium.
The Food and Drug Administration received 1,400 reports of failures for the Attune Knee System, with about 633 resulting in revision surgeries as of June 2017. The defendants are New Jersey-based Johnson & Johnson. DePuy Synthes, a Johnson & Johnson subsidiary, is one of the world’s largest manufacturers of artificial knee implants. Their Attune Knee System is the subject of personal injury and product liability lawsuits over claims of defective devices requiring intensive intervention.
Many experts have found there is an unusually high rate of early failures in the DePuy Synthes Attune Knee System. By June 2014, the FDA had received 1,400 reports (Manufacturer and User Facility Device Experience, or MAUDE database) about the failures of the device. Of those reports, 633 patients required revision surgery.
However, since its approval in August 2011, the FDA has received thousands of complaints from patients about complications with the Attune Knee System, namely that the tibial plate loosened and was incorrectly fixed to the tibia. This required revision and reconstructive surgeries.
And in an article recently published in the Journal of Knee Surgery, nine prominent orthopedic surgeons reported that they have encountered an unusually high-rate of premature failures of the Attune Knee System. Surgeons discovered that the “glue” typically used to hold an implant in place does not “stick” to the tibial component of the Attune Knee System. The tibial component of the Attune Knee System loosens, and the entire knee replacement is destabilized.
