Daily Archives: September 13, 2017

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New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions

Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Faulty St. Jude Riata Defibrillators may have Fatal Consequences

Patients who still have recalled St. Jude Defibrillators leads in their chests have many reasons to be vigilant. Premature insulation failure in the recalled device has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that leads to … Continue reading

Posted in Defective Medical Devices, Health Concerns, Product Recalls, Recalled Medical Devices, St. Jude Defibrillators |

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