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M. Brandon Smith

MAUDE Database Points to Problems with Exactech’s Optetrak Replacement Knee

First established in the early nineties, the Manufacturer and User Facility Device Experience—or MAUDE—database is mandated reporting system maintained by the Food and Drug Administration that allows for the posting of any event in which medical devices may have malfunctioned, […]

M. Brandon Smith

Manufacturer Exactech in Question as More Patients Fall Victim to Optetrak Knee Replacement Failure

Each year, more than 600,000 Americans have knee replacement surgery—a number that many believe will grow to one million within the next 10 years. Baby Boomers, once the largest living generation in history, have continued to age while still wanting […]

Richard R. Schlueter

New Stryker LFit V40 Femoral Head Hip Recall Coming Soon

Last week Childers, Schlueter & Smith, LLC published the Australian Health Hazard alert regarding the Stryker LFIT  V40 Femoral head.  CSS Firm has learned a list of affected lot numbers that includes hundreds of Lot and Item Numbers by Stryker. […]

M. Brandon Smith

No Morcellation Adverse Events Brought to FDA’s Attention for Eight Years

Although federal law requires the reporting of adverse events, no reports concerning power morcellators had been received by the U.S. Food and Drug Administration (FDA) prior to December 2013, according to The Cancer Letter. Prior to December 2013, the FDA […]

M. Brandon Smith

Study Questions Actual Worth of IVC Filters for Trauma Patients

A medical study published in the October 2015 issue of the Annals of Surgery takes a closer look at whether trauma patients actually benefit from having inferior vena cava (IVC) filters implanted, or instead face a greater risk of life-threatening […]

M. Brandon Smith

IVC Filter Lawsuit Alleges Failure, Migration of the Device

IVC filters are inserted through an artery and deployed with spider-like legs designed to both catch blood clots before they find their way to the lung and cause what could potentially be a fatal pulmonary embolism, and to hold the […]

Andy Childers

Lawsuit on Xarelto Claims Link to Ischemic Strokes and Other Bleeding Events

A lawsuit filed last week in state court in Philadelphia, Pennsylvania alleges that Xarelto’s recommended dosage doesn’t work for as long as is represented by the manufacturer, Janssen Pharmaceuticals and Bayer HealthCare. It is believed to be the first in […]

M. Brandon Smith

Bard G2 IVC Filter Complaint Filed in Georgia

A new complaint filed by Mr. and Mrs. Duffie of Georgia joins more than two dozen Bard G2 IVC filter lawsuits that have been centralized for pretrial proceedings before Arizona U.S. District Judge David G. Campbell. Atlanta injury law firm […]

M. Brandon Smith

FDA Strengthens Warning on Invokana Labeling

The U.S. Food and Drug Administration (FDA) recently revised its May 2015 warning to now include an increased risk of bone fractures and decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones. The original […]

M. Brandon Smith

New Study Highlights Perforation Risk of Cook Celect IVC Filters

Researchers from the University of Colorado and Northwestern University recently compared the retrievability factor of the Cook Celect IVC filter to the Reed Option filter and found that although retrieval figures between the two were similar, the perforation rate for […]