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M. Brandon Smith

Breaking News: First Georgia Case Filed Against Exactech for Issues with Optetrak Knee Replacement System

Medical device manufacturer Exactech has been making knee replacement components for a number of years now, servicing the growing market for joint replacement surgery that currently is a byproduct of aging Baby Boomers—once the largest living generation in history. This […]

Richard R. Schlueter

FDA Tracks Ongoing Optetrak Issues as Exactech Releases New Knee Replacement Product

In an effort to provide surgeons with an all-inclusive range of knee replacement systems, Exactech has recently announced the launch of their ExactechGPS TKA Plus—a software application that provides computer guidance within the body for orthopedic surgeons performing total knee […]

Richard R. Schlueter

Knee Replacement Surgeries are Growing and DePuy Attune Implants Could Be Failing: Are You Affected?

Currently, knee surgery is the most prevalent procedure performed on patients aged 45 years and older – totaling about 600,000 procedures in the U.S. and growing. Unfortunately, the increase in surgeries also brings with it an increase in knee replacement […]

Richard R. Schlueter

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, […]

Richard R. Schlueter

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 […]