BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC CONST LINER 52X28

    MDR report key: 1210526 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-05027
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    P960054/S02
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    HIP HEAD LUXATED OUT OF CUP IN SPITE OF A CONSTRAINED INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC CONST LINER 52X28 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA Z11DB1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention