DePuy Orthopedics, a division of Johnson & Johnson, is recalling 2 hip replacement systems in response to data showing more patients than expected required corrective surgery within 5 years.
The 2 products being recalled are the ASR XL Acetabular System, available worldwide, and the ASR Hip Resurfacing System, which is only sold outside the United States. The company says new data from the National Joint Registry of England and Wales shows that about 12% of hip resurfacing patients and 13% of the acetabular patients needed corrective surgery with 5 years of their initial hip replacement, with women more likely to require revision surgery than men.
DePuy spokeswoman Lorie Gawreluk says earlier data "had shown lower revision rates." The company discontinued both ASR hip systems last fall and is currently developing new versions.
In the meantime, DePuy President David Floyd says in a statement that the company is "committed to assisting patients and healthcare providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall." The recalled systems will be removed from hospital shelves, adds Ms. Gawreluk, and the company will help pay for monitoring of patients' conditions and any corrective surgery needed.
The recall announcement comes on the heels of a warning letter the FDA sent DePuy last week regarding 2 other products. In the letter, the agency ordered DePuy to stop selling its Corail Hip System for unapproved uses and to provide information on another product, the TruMatch Personalized Solution System, which the company has been selling even though it's not yet approved. The TruMatch system produces a 3-D view of the knee through CT scanning technology to facilitate the surgeon's positioning of knee implants.
Irene Tsikitas
