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Wright Medical Technology Changed Material in 2009, but Issued No Warnings or Recalls

Wed, 02/22/2012 - 6:45am
The Associated Press

PHOENIX--(BUSINESS WIRE)--Feb 22, 2012-- A Phoenix man filed a lawsuit today in U.S. District Court against Wright Medical Technology, Inc.

and Wright Medical Group, Inc. after needing emergency surgery following a sudden catastrophic fracture of the titanium modular neck of the Wright ProFemur Total Hip System as he was dressing for work last July.

Phoenix attorney Stephen Leshner of Stephen I. Leshner, P.C., and defective hip lawyer Joseph H. Saunders of Saunders & Walker, PA in Pinellas Park, Fla., filed the complaint against the Tennessee-based company on behalf of Dale Purcell, who had the device implanted in June 2005 during a total left-hip replacement.

The Wright ProFemur Total Hip System is comprised of three separate components which are assembled during surgery: a femoral head, a modular neck and the femoral stem.

"There is a design defect in the femoral implant that causes it to fracture just below the neck," Leshner said. "When it fractures, you're on the floor, in extreme pain and you have to have emergency surgery immediately." The nine-count complaint, which charges negligence, design defect, manufacturing defect, failure to warn and fraudulent misrepresentation, seeks unspecified general, special and punitive damages.

"One minute I'm standing there getting dressed for work and the next I'm on the ground," Parcell said. "At first I thought there was an earthquake that knocked me down, but then the pain hit and I couldn't move my leg." Purcell, 57, underwent revision surgery at Chandler Regional Medical Center on July 7, 2011, when surgeons had to remove the "fractured fragments of the ProFemur Z titanium modular femoral neck" and noted "some mild corrosion" at the site of the fracture, according to the complaint.

According to the complaint, "The titanium modular neck used in Mr.

Parcell fractured and broke very near the femoral stem, leaving a broken portion of the titanium neck wedged inside the stem. The fracture of the modular neck adapter caused failure of the system, requiring corrective surgery, and made it extremely difficult to extract the fragment." The complaint points out that "studies have shown that modular neck adapters made from titanium alloy, such as the ProFemur modular neck adapter" "are more likely to suffer fretting corrosion and fatigue fracture than those made from cobalt-chromium." A 2009 report by the Australian Orthopaedic Association showed that the Wright ProFemur Z femoral stem had a high failure rate, requiring approximately 11.2 percent of all patients receiving the implant to need revision surgery.

According to the complaint, in 2009, Wright Medical changed the material in the ProFemur Hip System Modular Necks from titanium to cobalt chrome alloy, but the company took "no corrective action in the form of a recall or even an announcement of warning to the medical community or to the public at large concerning its decision to switch from titanium modular neck adapters to cobalt chrome adapters." "At all relevant times, Defendants knew, or should have known, that the Device which included a titanium modular femoral neck was more prone to fatigue fracture and failure than a device made with a cobalt chromium modular neck," according to the complaint.

Leshner said this is the first of several lawsuits he expects to file on behalf of individuals who suffered similar failures of the hip-replacement device.

CONTACT: Stephen I. Leshner, P.C.

Stephen I. Leshner, 602-266-9000 or The Kur Carr Group, Inc.

Steve Carr, 602-317-3040 scarr@fastq.com KEYWORD: UNITED STATES NORTH AMERICA ARIZONA FLORIDA TENNESSEE INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES PROFESSIONAL SERVICES LEGAL SOURCE: Stephen I. Leshner, P.C.

Copyright Business Wire 2012 PUB: 02/22/2012 11:33 AM/DISC: 02/22/2012 11:33 AM http://www.businesswire.com/news/home/20120222006265/

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