Rocky Thompson recently filed a product liability lawsuit filed against Johnson & Johnson the world’s largest pharmaceutical and medical device maker and it’s DePuy Synthes subsidiary.
According to lawsuit allegations, thousands of patients had to undergo painful extensive revision surgery to remove and replace defective DePuy Attune knee devices.Thompson claimed that the DePuy Attune knee replacement failed prematurely leading to painful revision surgery. Thompson filed in the U.S. District Court for the Middle District of Louisiana claiming that the popular DePuy Attune Knee implant is defectively designed and unreasonably dangerous. According to Thompson, he underwent a knee replacement in 2015, with the DePuy Attune system utilizing a fixed tibial insert and fixed tibial baseplate. But within a few years, he developed severe pain and instability requiring revision surgery to remove the DePuy Attune knee. The DePuy Attune knee implant failed because of a lack of bond and failure at the tibial baseplate-cement interface. In other words, the “glue” or cement that was designed to hold the device together failed.
What is the DePuy Synthes Attune Knee system?
The DePuy Synthes Attune Knee system was approved by the FDA in 2010, and sold in early 2013. The DePuy Attune system became a blockbuster device, with over 400,000 DePuy Attune knee implants sold worldwide.
What is the problem with DePuy Synthes Attune Knee system?
According to lawsuit allegations, thousands of patients had to undergo painful extensive revision surgery to remove and replace defective DePuy Attune knee devices. Patients blame the faulty knee implant device for severe pain, swelling, and instability in the knee caused by loosening of Attune’s tibial baseplate part from the baseplate-cement interface. Many patients have developed serious side effects including fractures, infection, soft tissue injury and permanent damage after unavoidable revision surgery.
FDA bombarded with DePuy Synthes Attune Knee system failure reports
The FDA has already about 1,400 reports involving failure with DePuy Attune knee replacements, including at least 633 cases where patients have already had revision surgery.
Medical Report of early failure
The researchers in the Journal of Knee Surgery found that the DePuy Attune knee implant system had high rates of tibial loosening and premature failures, highlighting concerns about problems at the implant-cement interface. The issue is mechanical loosening, caused by the failure of the bond between the tibial baseplate and the implant-cement surface. The lawsuits allege that when the loosening occurs, the artificial knee can detach from the existing bone, causing knee implant failure. When the artificial knee replacement loosens, it can cause pain and chip away at the bones. This can lead to reduced physical movement because of severe pain, and ultimately the device fails, causing loss of knee function.