BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN MB INSERT SZ3 9.5MM

    MDR report key: 1002227 · Received February 20, 2008

    Report

    Report Number
    1818910-2008-00289
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 22, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    NJL
    PMA / PMN Number
    P910016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    REVISION SURGERY. PROSTHESES LOOSENING AND POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRSVN MB INSERT SZ3 9.5MM 87NJL NJL DEPUY INTERNATIONAL, LTD. NA YAD79

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention