BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID DIA 36

    MDR report key: 1143630 · Received August 28, 2008

    Report

    Report Number
    1818910-2008-03700
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    DEPUY FRANCE, S.A.
    Product Code
    KWS
    PMA / PMN Number
    K021478
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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

    THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, POLY WEAR AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLENOID DIA 36 87KWS KWS DEPUY FRANCE, S.A. NA 1220246

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention