Ohio Couple Sues Arthrex, Citing Knee Arthroplasty Failure: What Did the Manufacturer Know and When Did They Know It?
When Amanda Vanderburg (not her real name) underwent replacement of both knees in December 2014, everything went smoothly, with no complications. The prostheses used were of a model called the “iBalance,” a product of Arthrex, a company specializing in orthopedics involving less invasive procedures. Arthrex touts its product as “...a complete, minimally invasive instrument and implant platform for the treatment of localized unicondylar cartilage degeneration as the result of osteoarthritis or post-traumatic arthrosis [joint inflammation and degeneration due to injury] in the medial or lateral compartments of the knee.”
For a short time, all was well. The operation on her left knee was a success – but within weeks, Amanda began experiencing pain and swelling in her right knee. These were symptoms indicating that her new knee prosthetic was destabilizing, which ultimately caused her to develop an odd gait. Eventually, a bone scan and x-ray revealed that a major component of the implant had come loose. Just eighteen months after the prosthesis was implanted, Amanda was readmitted to the hospital, where her surgeon was able to remove the defective component simply by pulling on it by hand.
As has been the case with knee replacements from DePuy and Exactech, the cement used to attach the component (in this case, the tibial tray, which attaches to the top of the shin bone) had failed to do its job. Because of the defects inherent in the product, Amanda has suffered permanent injuries, enduring debilitating pain and emotional trauma, while her husband has lost the companionship he once enjoyed. According to the complaint, the Arthrex iBalance was “defectively designed and/or manufactured in that the iBalance knee implant failed to withstand normal and reasonable use,” and that the company either knew, or should have been aware that it “would be used by users without any knowledge of their product defects and inherent dangers and without any inspection for dangers and defects.” The lawsuit further alleges that the iBalance is “more dangerous than an ordinary consumer or user would expect” and that the purported benefits of the prosthesis “outweigh the risks inherent in the design and configuration.”
Amanda has a strong case. First of all, the tibial tray component was fast-tracked to FDA approval the year before Amanda underwent her operation, through the 510(k) Premarket Notification process. Arthrex was not required to run clinical tests of the component; they simply informed the FDA that it was “substantially equivalent” to an existing model. A year after Amanda's operation, the company issued an “Urgent Medical Device Voluntary Recall” notice to surgeons and medical facilities. As a result, over 2,300 tibial trays were returned to Arthrex. Meanwhile, the FDA received a high number of reports of device failures, issuing its own Class 2 Recall shortly thereafter.
Later, Arthrex quietly introduced a replacement for the defective device. All things considered, it is difficult to believe that the manufacturer was unaware of the problems with its iBalance prosthesis prior to its “voluntary” recall.