Posts Tagged 'early failure'

FDA calls for limits on selling all-metal hips

The U.S. Food and Drug Administration is proposing a policy that could prevent manufacturers from selling dangerous metal-on-metal hip implants, according to a story in the New York Times.

The story says all-metal hips – which have both a ball and a socket coated with a combination of cobalt and chromium – have been plagued by high early failure rates.

Traditional hip ...

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FDA warns against all-metal implants

The U.S. Food and Drug Administration says metal-on-metal hip implants, which feature both a ball and a socket coated in a mixture of cobalt and chromium, can cause soft-tissue damage. According to a Reuters story, the agency warns that the implant defects can make further surgery necessary.

The problem, according to the FDA, is that the implants can shed metal debris when the ball and socket slide against each other during ...

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J&J official: Company knew mesh devices were dangerous

During a trial over vaginal mesh implants, a Johnson & Johnson official testified that the company was well aware the medical devices were dangerous before putting them on the market in 2005.

In the first of 1,800 such lawsuits to go to trial, a 47-year-old South Dakota woman named Linda Gross is suing over allegations that the health care giant failed to adequately test the devices or warn patients of their ...

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Congressional investigators accuse J&J of misconduct

A CNN story concerns a congressional investigation into pharmaceutical giant Johnson & Johnson, based on reports that the company tried to mislead the public about defective products.

Specifically, the story focuses on an alleged “phantom recall” of painkiller Motrin. According to the story, the U.S. Food and Drug Administration eventually initiated a nationwide recall of more than 88,000 Motrin tablets because of a problem with the way the drug dissolved.

But the ...

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Woman’s case a bellwether for faulty hip implants

The Rochester Business Journal out of New York says an area woman’s lawsuit is one of two bellwether cases that will affect the outcome of thousands of claims concerning DePuy Orthopaedics hip implants.

Local businesswoman Ann McCracken, 57, had an all-metal hip joint implanted in 2009. According to the story, it was “marketed as particularly appropriate for younger, more active candidates.”

DePuy, a division of Johnson & Johnson, recalled the implants in ...

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Federal agency gives warning on metal hips

The U.S. Food and Drug Administration Website cautions that while all artificial hip replacement systems carry risks that the devices will break down or wear out, those risks are particularly high with “metal-on-metal” implants.

A metal-on-metal implant features both a ball and a cup coated with a combination of cobalt and chromium. The FDA says the metal components slide against each other when the recipient is walking or running, and tiny ...

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