Just days before Johnson & Johnson announced a voluntary recall of hip replacement parts the company received a warning letter from the U.S. Food & Drug Administration (FDA) about illegally marketing other joint replacement products. Both the recalled hip-replacement parts and the joint replacement products are manufactured and distributed by J&J’s DePuy Orthopaedics Inc. subsidiary.
The recall involves the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. The parts were recalled after studies showed a much higher than normal rate of repeat surgeries required by people who had received the parts. It is estimated that 93,000 people may be affected by this recall. Patients are reporting pain, swelling and trouble walking. Problems include loosening and/or dislocation of the hip replacement parts, as well as bone fractures around the parts. Additionally, metal shavings from the faulty hip replacement parts can damage surrounding tissue and bone in the hip area.
The FDA warning involves another hip replacement system, as well as equipment used for diagnostics prior to knee replacement surgery. According to the FDA, DePuy was incorrectly marketing its Corail Hip System for two unapproved uses, and promoting those uses in a brochure online. Also, the agency says DePuy has been selling its TruMatch Personalized Solution System, which provides software and CT scanning to create a 3-D image of a patient’s knee prior to receiving a knee implant, without FDA approval.
The warning letter was issued Aug. 19, and the hip replacement parts were recalled Aug. 26. These incidents are just the latest in a line of troubles for Johnson & Johnson involving defective products. In less than a year, the company has issued eight recalls in the U.S. of over-the-counter medications such as Tylenol and Motrin, some of which were found to be contaminated with metal shavings and other debris. Johnson & Johnson also issued a recall in August for 1 Day Acuvue True Eye contact lenses sold in Asia and Europe.