BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR 10D LINER 28IDX52OD

    MDR report key: 1033569 · Received April 23, 2008

    Report

    Report Number
    1818910-2008-01174
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K994415
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PT WAS REVISED BECAUSE THE LINER AND LOCKING RING WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR MAR 10D LINER 28IDX52OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA W5KC31008

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention