BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML DURALOC POLY LINER

    MDR report key: 1251324 · Received December 3, 2008

    Report

    Report Number
    1818910-2008-05964
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    PMA / PMN Number
    NA
    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

    THE PATIENT HAS HAD PROXIMAL BONE LOSS (OSTEOLYSIS) AROUND THE GREATER TROCHANTER, AND THE STEM BECAME LOOSE. STEM MANUFACTURED BY OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML DURALOC POLY LINER TOTAL HIP REPLACEMENT KWB DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention