BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUGMENTED INSERT

    MDR report key: 2151008 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-12173
    Event Type
    Injury
    Date Received
    June 30, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    K001523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    FAILURE DUE TO NECROSIS OF PERI-IMPLANT BONE AND SOFT TISSUE FROM MASSIVE METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUGMENTED INSERT 87 KWA KWA DEPUY INTL., LTD. NA 1112512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention