BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEXFLEX TOTAL HIP SYSTEM

    MDR report key: 777653 · Received August 29, 2006

    Report

    Report Number
    2027467-2006-00010
    Event Type
    Other
    Date Received
    August 29, 2006
    Date of Event
    July 24, 2006
    Report Date
    August 29, 2006
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    JDI
    PMA / PMN Number
    k952629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PART INVOLVED. FEMORAL STEM (POROUS) 8MM X 125MM PART NUMBER 70010-01 LOT NUMBER 604853, ASSOCIATED WITH NEXFLEX FEMORAL STEM (STANDARD POROUS COATED) 510K# K955171. THE LOCK FUNCTION BETWEEN THE FEMORAL STEM AND THE FEMORAL HEAD WAS DISENGAGED DUE TO EXCESSIVE LOAD ON THE CONSTRUCT WHEN THE PT ATTEMPTED SUICIDE. THE DISENGAGED PARTS REMAIN IN THE PT.

    Description of Event or Problem · 1

    THE LOCK FUNCTION BETWEEN THE FEMORAL STEM AND THE FEMORAL HEAD WAS DISENGAGED, DUE TO EXCESSIVE LOAD ON THE CONSTRUCT WHEN THE PT ATTEMPTED SUICIDE. THE DISENGAGED PARTS REMAIN IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEXFLEX TOTAL HIP SYSTEM FEMORAL HEAD MEDIUM JDI ALPHATEC SPINE, INC. 72100-03 604853

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR