BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 49

    MDR report key: 2093858 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-07152
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 19, 2011
    Report Date
    November 13, 2015
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS PAIN, ALVAL, OSTEOLYSIS, AND COMPONENT MALPOSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 49 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 1132843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention