Hip devices recalled
TRENTON, N.J. — Johnson & Johnson’s artificial joint business is recalling two hip-replacement products, two days after a government warning that it is illegally marketing two other products. It is the 11th J&J recall since September.
DePuy Orthopaedics Inc. said it is recalling the hip-replacement products because new data show higher-than-expected rates of patients needing second hip-replacement procedures, about 12 percent.
Within five years, one in eight patients needed a revision surgery. That is required when an artificial joint does not fit perfectly, causing pain and difficulty walking. The products are the ASR Hip Resurfacing System and the ASR XL Acetabular System.
“We are committed to assisting patients and health care providers by providing information . . . and paying for the cost of doctor visits, tests, and procedures associated with the recall,’’ said David Floyd, president of DePuy Orthopaedics in Warsaw, Ind.
That includes monitoring how well a patient’s hip is working and paying for any corrective surgery. Products still on hospital shelves will be removed.
Each of the metal systems is used to replace a worn or weakened part of the hip, which consists of a socket at the outer edge of the pelvis and a rounded bone atop the thigh bone that fits into that socket like a ball. Total hip replacement involves replacing both parts at once.
On Tuesday, the Food and Drug Administration told DePuy to stop selling its Corail Hip System for two unapproved uses and to provide data needed to review another product DePuy has been selling without approval.