BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS 24MM DIAPHYSEAL SLEEVE

    MDR report key: 1885149 · Received October 22, 2010

    Report

    Report Number
    1818910-2010-07808
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MBH
    PMA / PMN Number
    K071417
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    JUNCTION BETWEEN DIAPHYSEAL SLEEVE AND BASEPLATE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LPS 24MM DIAPHYSEAL SLEEVE 87MBH; 87JWH MBH DEPUY ORTHOPAEDICS, INC. NA B4EGR1000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention