BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT LS INSERT SM 15MM

    MDR report key: 1651147 · Received March 31, 2010

    Report

    Report Number
    9610726-2010-00099
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSH
    PMA / PMN Number
    K872735
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PREOP: LINER EXCHANGE. OUTCOME: ALL COMPONENTS PULLED-LOOSENED TIBIA SURGEON ELECTED TO GO TO A ZIMMER LCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURAT LS INSERT SM 15MM IMPLANT HSH STRYKER ORTHOPAEDICS LIMERICK NA 7VMT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention