BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE CALCAR PLANNER

    MDR report key: 774422 · Received October 25, 2006

    Report

    Report Number
    2249697-2006-00127
    Event Type
    Injury
    Date Received
    October 25, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 2, 2006
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KHY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED "SURGEON IMPLANTED A 52MM TRIDENT PSL CUP WITH A 36MM 0 DEGREE CROSSFIRE INSERT. AXIAL REAMED AND THEN BROACHED THE FEMUR TO A PRESSFIT #9 USING THE CUTTING EDGE ADVANTAGE GOLD INSTRUMENTS. PLACED THE 1020-2700 CALCAR PLANER ON A POWER REAMER IN THE USUAL FASHION AND PLACED THE PLANER ON THE PEG TRUNION OF THE INSERTED BROACH. DURING THE PLANING PROCESS, A LARGE PIECE OF CALCAR BONE WAS BROKEN AWAY. REQUIRING THE USE OF AN INHOUSE 1.7MM SYNTHES COCR ORTHOPAEDIC CABLE TO REPAIR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE CALCAR PLANNER INSTRUMENT KHY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention