BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX PLUS FEM CONDY POROUS LRG

    MDR report key: 864762 · Received June 12, 2007

    Report

    Report Number
    2249697-2007-00074
    Event Type
    Injury
    Date Received
    June 12, 2007
    Date of Event
    May 18, 2007
    Report Date
    May 18, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS MAHMAH
    Product Code
    HSA
    PMA / PMN Number
    K910500
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS PROVIDED BY A RESEARCH FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS THE SAME PATIENT AND EVENT AS REPORT #9610726-2007-00020.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE ARTHROPLASTY WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AND THE TIBIAL TRAY. THE TIBIAL INSERT, TIBIAL TRAY AND FEMORAL COMPONENT WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 11.68 YEARS (APPROX. 11 YEARS 7 MONTHS)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX PLUS FEM CONDY POROUS LRG IMPLANT HSA STRYKER ORTHOPAEDICS MAHMAH NA BRWRB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention