BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT INSERT XL 8MM

    MDR report key: 2272512 · Received September 28, 2011

    Report

    Report Number
    9610726-2011-00345
    Event Type
    Injury
    Date Received
    September 28, 2011
    Date of Event
    September 20, 2011
    Report Date
    September 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSX
    PMA / PMN Number
    K872735
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT DISCARDED. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE DOCTOR REMOVED THE WORN OUT TIBIAL INSERT AND REPLACED IT WITH A NEW TIBIAL INSERT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURAT INSERT XL 8MM IMPLANT HSX STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention