Wright Medical must submit a decade of data on metal hip implants
Medical device maker Wright Medical has been asked by the U.S. Attorney’s Office for the Western District of Tennessee to pony up records relating to its line of metal hip implants dating back to January 1, 2000. Wright manufactures metal hip stems and total hip replacement systems.
Metal hip implants have been the center of much controversy in the past two years since DePuy Orthopaedics, a subsidiary of Johnson & Johnson, recalled its ASR Acetabulator metal-on-metal hip replacement system. The recall led to an investigation that found that the metal-on-metal design used by several manufacturers of hip implants has serious flaws that may lead to premature failures and corrosion of parts that could put patients at risk for blood poisoning.
The Food and Drug Administration (FDA) ordered more than 20 manufacturers of metal-on-metal hip replacement systems to gather data on their all-metal devices. An advisory panel recently fell short of banning the implants, but said the devices have little value on the market.
Last month, orthopedic joint maker Stryker Orthopaedics issued a recall of its Rejuvenate Modular and ABG II modular neck hip stems because of a risk that the parts could fret or corrode at the neck junction, which could cause pain, swelling and blood poisoning. The Stryker hip implant is not a full hip replacement system but an attachment for artificial hips that allows them to fit in a patient better. The Stryker device is not made from all metal parts, but does have metal components.
Wright defended its products in its latest earnings report: “Although Stryker’s recalled modular hip stems differ in design and material from our Profemur modular neck hip stems, there is a risk that Stryker’s recall and the resultant publicity could negatively impact sales of modular neck systems of other manufacturers, including our Profemur system, even if the issues cited by Stryker are unique to Stryker products.”
Source: Mass Device
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