BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE PLUS SZ 2 FLANGED

    MDR report key: 889636 · Received August 2, 2007

    Report

    Report Number
    1818910-2007-02385
    Event Type
    Injury
    Date Received
    August 2, 2007
    Date of Event
    July 3, 2007
    Report Date
    July 6, 2007
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWY
    PMA / PMN Number
    K871867
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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

    REVISION DUE TO LOOSENING OF STEM. WEAR OF HYLAMER LINER ALSO MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE PLUS SZ 2 FLANGED 87JCX KWY DEPUY INTERNATIONAL, LTD. NA 00JWW-08000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention