J&J Recalls 93,000 Defective Hips
DePuy which has sold about 93,000 units its ASR XL Ace tabular Systems and the ASR Hip Resurfacing System, said recent data receive by the company showed an increase in the number of people who have had a second hip replacement surgery, also called a “revision surgery.”
Both products were discontinued late last year. The company said information showed that five years after implantation, approximately 12.5% of patients, or one in eight, who had received the ASR resurfacing device, and 12.5% of patients, or one in eight, who had received the ASR total hip replacement, needed a second surgery. Pain, swelling, and problems walking are among the symptoms that patients complained about, the company said. If those symptoms continue, they could lead to more significant complications including loosing of the implant, fracture of the hip bone and dislocation of the implant, the company said.
DePuy said it will cover reasonable and customary costs of monitoring and treatment for services,” including additional surgery costs associated with the recall of ASR systems. This recall marked the second problem for the Johnson & Johnson unit in a week.
The FDA issued a warning letter of DePuy for selling hip and other joint products without the agency’s approval. The FDA said the medical devices maker has been selling its TruMatch Personalized Solutions Systems, which makes artificial knee products, and the Hip System without “market clearance” and in violation of the Federal Food, Drug and Cosmetic Act.