In an August 8 complaint filed in the U.S. District Court District of Pennsylvania, a plaintiff alleges that Arthrex Inc.’s recalled iBalance knee replacement device, he was implanted with, was faulty and required him to undergo a revision surgery. The plaintiff blames the company for conducting inadequate testing before exclusively marketing the device. The device was recalled in February 2015, when Arthrex sent out urgent medical device voluntary recall letters to distributors, surgeons, and medical centers, reporting the removal.
More than 4 million Americans have undergone a knee replacement, and thousands have reported faulty device designs. Around 2,378 Arthrex iBalance units were affected by the 2015 FDA Class II recall. DePuy Synthes Attune, Zimmer, and several other manufacturers are facing claims over faulty knee replacement systems causing severe internal injuries to patients.
