BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR NEUT LINER 28IDX58OD

    MDR report key: 1872919 · Received October 14, 2010

    Report

    Report Number
    1818910-2010-07005
    Event Type
    Injury
    Date Received
    October 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    DEPUY INT'L, LTD.
    Product Code
    LPH
    PMA / PMN Number
    K994415
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 REPORT STATES: THE PATIENT WAS REVISED TO ADDRESS POLY WEAR OF THE ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR MAR NEUT LINER 28IDX58OD 87LPH LPH DEPUY INT'L, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention