Tuesday, February 19, 2013

J&J Warns of Safety Risk For 7,500 Non-US Hip Implants

Bloomberg has;
J&J Warns of Safety Risk For 7,500 Non-US Hip Implants
By Shannon Pettypiece & Michelle Fay Cortez - Feb 15, 2013 12:01 AM ET

Johnson & Johnson, the largest seller of health-care products, alerted doctors outside the U.S. to stop using the company’s Adept hip implant after a higher- than-expected failure rate.
A U.K. database found that 12 percent of patients needed a repeat surgery to fix the implant, which hasn’t been sold since 2011, the New Brunswick, New Jersey-based company said yesterday in a statement. About 7,500 of the hips were distributed in 21 countries, not including the U.S. Doctors were sent a safety notice on Jan. 14 about the product.
J&J recalled 93,000 of its ASR model hips in August 2010 and faces 10,000 lawsuits related to the products. The patients that are suing claim the implant left them in pain or immobilized by joint dislocations, infections and bone fractures. They also complain of high levels of cobalt and chromium ions from wear on the devices, in which a metal ball placed atop the femur rotates in a cup implanted in the hip.
J&J acquired the Adept implant in 2009 from closely held U.K. device maker Finsbury Orthopaedics Ltd. J&J said patients who received the Adept devices should be followed according to local standards of care.
Both recalled hip models have the metal-on-metal surfaces.
To contact the reporters on this story: Shannon Pettypiece in New York atspettypiece@bloomberg.net; Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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