Johnson & Johnson has again recalled thousands of its hip implants, 2 1/2 years after the problem-plagued health care giant issued a recall of two other types of its artificial hips.
Spokeswomen for J&J's DePuy Orthopaedics unit said that the company recalled the "Adept" brand all-metal total hip replacement system starting last month because a higher-than-expected percentage of them had to be replaced. Such replacements, called revision surgeries, usually are needed when an artificial joints starts causing pain, difficulty walking or other problems.
The recall involves only the top part of the hip replacement system, the ball at the top of the thigh bone that fits into the hip's socket.
J&J said it's recalled all 7,500 Adept implants shipped worldwide between 2004 and September 2011. That's when it sold the product back to the company that had developed Adept and had sold the rights to it to the DePuy business in 2009.
According to J&J, the implants were sold in Germany and 20 other countries, but not in the U.S.
J&J said it notified surgeons and hospitals about the recall on Jan. 14 after reviewing data from national registries on joint replacements in two countries. A registry in the United Kingdom found that 12.1 percent of patients needed their implants replaced within seven years, while a registry in Australia found 7.1 percent of patients needed replacements within three years.
The DePuy spokeswomen did not know how many of the recalled implants were implanted in patients. Any who have the implants and are having problems with them should contact their doctor.
The recall was originally reported by the German newspaper Handelsblatt.
J&J noted the recall does not involve a product called Adept Hip Resurfacing Femoral Components.
Johnson & Johnson has issued more than 30 product recalls since 2009. Most have involved nonprescription medicines such as adult and children's Tylenol and Motrin, but other recalls were for prescription drugs for conditions such as epilepsy or for contact lenses. Reasons have included wrong levels of active ingredients in medicines, glass or metal shards in liquid medicines and nauseating packaging smells.
The company is operating under increased scrutiny from the U.S. Food and Drug Administration, while it completely rebuilds one nonprescription medicine factory from the ground up and upgrades other factories. The recalls and lost product sales have cost J&J well over $1 billion.
In August 2010, the company recalled two types of DePuy ASR metal hip implants after they were linked to high failure rates. Those recalls have led to thousands of lawsuits by U.S. patients.
In the first of those cases to reach trial, a jury in Los Angeles three weeks ago began hearing testimony in a lawsuit brought by a former North Dakota prison guard who got one of the implants to relieve arthritic pain, but had to have it replaced.
Lawyers for Loren Kransky told jurors that black pieces of metal flaked off the implant and caused a type of metal poisoning that could have killed him if the material had not been removed. But a Johnson & Johnson lawyer said the 64-year-old Kransky had many pre-existing medical ailments.
Date: February 15, 2013
Source: Associated Press