Johnson & Johnson’s orthopedic-device unit is recalling hip replacement parts implanted in about 93,000 people world-wide because of a high rate of repeat surgeries needed, adding a new quality problem for the health-products company.
A Johnson & Johnson spokesman said Thursday the company is still evaluating the financial impact of the recall, which doesn’t require patients to have implants removed. Instead, the company’s DePuy Orthpaedics subsidiary advised patients with its ASR hip parts to visit their surgeons for evaluation of device performance. It also recommended yearly monitoring and said it plans to cover “reasonable and customary costs” linked to the recall.
Very few of these hip systems remain on the market, DePuy said, since the company decided to discontinue sales last year, citing declining demand, and to focus on new products. Problems leading to repeat surgery included loosening parts, infections, fractures, dislocation, and sensitivity to metal and pain, the company said.
The recall announcement comes on the heels of a recent Food and Drug Administration warning letter to DePuy, disclosed earlier this week, saying the company was marketing some different replacement-joint products without required approval. DePuy said it had received the FDA’s letter and would respond to the agency’s request for information.
The recalled devices are called the ASR XL Acetabular System, which is the cup portion of a replacement hip joint, and the ASR Hip Resurfacing System. Resurfacing involves implanting a cup and capping the ball at the top of the thighbone in a procedure that preserves more bone than traditional replacements, and is geared toward younger patients. The ASR XL system was first launched in 2004 and sold world-wide, while the resurfacing system was launched in 2003 but has only been approved outside the U.S.
The recall adds to J&J’s recent stretch of quality issues. The company’s McNeil Consumer Healthcare unit has issued several recalls of over-the-counter drugs since late 2009, including an April recall of more than 136 million bottles of liquid children’s medicines due to such quality problems as higher-than-appropriate concentrations of active ingredients and the presence of metal particles. More recently, J&J’s Vision Care Inc. unit recalled 100,000 boxes of certain contact lenses in parts of Asia and Europe because of a manufacturing problem.