BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT LS INSERT MED 8MM

    MDR report key: 1635130 · Received March 15, 2010

    Report

    Report Number
    9610726-2010-00084
    Event Type
    Injury
    Date Received
    March 15, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSX
    PMA / PMN Number
    K872735
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR.#9610426-2010-00085.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FEMORAL COMPONENT WORE THROUGH THE TIBIAL INSERT. THE FEMORAL COMPONENT ARTICULATED WITH TIBIA TRAY AND THE TIBIA TRAY BROKE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention