BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 28IDX52OD

    MDR report key: 1053587 · Received May 22, 2008

    Report

    Report Number
    1818910-2008-01715
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K001534
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ACETABULAR LINER APPEARED TO HAVE WORN ON XRAY. NOTED OSTEOLYSIS AND POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR +4 10D 28IDX52OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA VC5A31084

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention