BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 2574495 · Received May 7, 2012

    Report

    Report Number
    3005985723-2012-00094
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    April 27, 2011
    Report Date
    April 26, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP AN EVALUATION WAS PERFORMED BY MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO) SYSTEM. THE SURGEON INVOLVED IN THE EVENT USED THE CORRECT MEASURES TO ENSURE PLANNING ACCURACY. BY GIVING PRIORITY TO IMPLANT ALIGNMENT OVER IMPLANT TRACKING, IT CAN BE ENSURED THAT THE IMPLANTS WILL BE APPROPRIATELY PLANNED IN RELATION TO THE PATIENT ANATOMY. THE RESTORIS MCK PLANNING AND SURGICAL TECHNIQUE USER GUIDE WAS UPDATED TO INCLUDE A CLARIFICATION THAT IMPLANT ALIGNMENT SHOULD TAKE PRIORITY OVER IMPLANT TRACKING FOR LATERAL CASES.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2011. IN THE IMPLANT PLANNING PAGE, THE SURGEON OBSERVED A MEDIAL SHIFT OF THE FEMUR AND FIVE RED TRACKING POINTS ON THE LATERAL SIDE OF THE FEMORAL CONDYLE IN THE MODEL. THE MAKOPLASTY SPECIALIST (MPS) LATERALIZED THE FEMORAL AND TIBIAL COMPONENTS IN THE PLAN UNDER THE SURGEON'S GUIDANCE. THE SURGEON THEN RECAPTURED JOINT BALANCING POSES TWICE AND RE-REGISTERED THE FEMUR, BUT THE SAME RESULT WAS SEEN. THE SURGEON PROCEEDED WITH THE CASE AND OBSERVED THAT CONTRARY TO THE SYSTEM MODEL, THE IMPLANTS TRACKED RIGHT DOWN THE MIDDLE AS DESIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 201000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA