Johnson & Johnson recalls hip implants

Devices sold abroad wearing out more than expected, health-care company says

— Johnson & Johnson has again recalled thousands of its hip implants, 2 1/2 years after the health-care giant issued a recall of two other types of its artificial hips.

Spokesmen for Johnson & Johnson’s DePuy Orthopaedics unit said Thursday 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 artificial joints start 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.

New Brunswick, N.J.-based Johnson & Johnson said it’s recalled all 7,500 unused Adept implants shipped worldwide between 2004 and September 2011.

According to Johnson & Johnson, the implants were sold in Germany and 20 other countries, but not in the U.S.

Johnson & Johnson 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 spokesmen 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 reported Thursday by the German newspaper Handelsblatt.

Johnson & Johnson said the recall does not involve a product called Adept Hip Resurfacing Femoral Components.

Johnson & Johnson, the world’s biggest provider of health-care products, 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 odor.

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 Johnson & Johnson 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 Kransky, 64, had many pre-existing medical ailments.

Johnson & Johnson shares rose 15 cents to close at $75.81 on Thursday after rising as high as $76.09 earlier in the session. FactSet said that was an all-time high for the stock.

Information for this article was contributed by Frank Jordans of The Associated Press.

Business, Pages 28 on 02/15/2013

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