BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODULAR HIP

    MDR report key: 1943627 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00674
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K984227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE MODULAR NECK DISENGAGED FROM THE STEM AND DISLOCATED THE HIP. THE DOCTOR WANTS TO KNOW IF THERE IS A FLAW WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HIP MODULAR FEMORAL NECK JDI ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention