DePuy Attune Knee Replacement Can Result in Physical, Emotional and Financial Pain

November 21, 2017, 8:00AM. By Jane Mundy

Santa Clara, CAIt’s pretty much a straightforward decision for most of the 700,000 people in the U.S. who experience knee pain yearly: have a knee replacement or live the rest of your life in pain. But for some people implanted with a defective knee such as the DePuy Synthes Attune device, they made the wrong decision and the consequences have been brutal. As a result, they are filing knee replacement lawsuits against DePuy, alleging premature failure of the Attune device.

The DePuy Attune, like so many other metal-on-metal hip and knee replacements, can become worse than the actual knee it replaced as the patient tries to live with basically normal movement, normal lifestyle changes for more than a few years.

During an interview with Ring of Fire co-host Farron Cousins, attorney Daniel Nigh said that, if you had a knee replacement in the last six or seven years, you probably have somewhere between a 10 percent to 30 percent chance of having this knee replacement device—it seems to be the flavor of the year. And the reason the device fails has to do with tibial debonding—the cement is not bonding to the tibial base plate. “Without cement bonding to the tibia, you’ve basically got this loose part just flapping all around inside of there. You won’t notice it for maybe the first year or so. But in time, as you move on that knee more and more, there’s going to be problems with it,” said Nigh.

One of those problems is revision surgery, which is more complicated than the initial knee replacement and recovery time can take up to 50 percent longer than replacement surgery recovery. These devices are supposed to last at least 15 years, but the Attune’s lifespan averages less than two years.

Not only is there the physical setback. Time means money and most Attune recipients are in a younger age bracket, meaning they may have a full-time job. Not every employer is able to give three months off –or more—for revision surgery. In fact, the American Academy of Orthopedic Surgeons says that half the patients now receiving knee replacements are younger than 65 years of age, and most of them are in the workforce.

But don’t just take an attorney’s word for it. According to a recent study published in the Journal of Knee Surgery (September 18, 2017), the DePuy Synthes’ Attune total knee arthroplasty system is experiencing an “unusually high” rate of early failure related to its tibial components. The study involved 232 reports by patients with the Attune system who required revision surgery, and in the FDA’s MAUDE system. In just the past two months before the study was published, researchers noted 21 reports made to MAUDE of tibial loosening at the so-called "implant-cement interface", with "numerous other tibial failures" reported.

The researchers reviewed three hospital databases for patients diagnosed with tibial loosening at the implant-cement interface, and found 15 cases. "Patients presented with pain on weight bearing, effusion, and decreased range of motion (ROM) within two years after surgery” said the researchers, who also found two cases with loosening of the tibial components. According toMass Device, their findings “demonstrated gross loosening of the tibial component at the implant-cement interface.” While only 15 cases out of 232 reports in the MAUDE database seems negligible, how many patients would they find suffering from their Attune knee premature failure if every case was reported to the FDA?