BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 3140937 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-17979
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    February 13, 2013
    Report Date
    May 22, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN THE BLOODSTREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244982 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention