BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR MAR 10D 32IDX56OD

    MDR report key: 1033944 · Received April 24, 2008

    Report

    Report Number
    1818910-2008-01265
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 25, 2008
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    LPH
    PMA / PMN Number
    K994415
    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

    PT PRESENTED WITH PAIN. REMOVED FEMUR, LINER AND HEAD DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR MAR 10D 32IDX56OD 87LPH LPH DEPUY INTL, LTD NA Y4RDG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention