BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 2574506 · Received May 7, 2012

    Report

    Report Number
    3005985723-2012-00091
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    April 20, 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
    NJ, 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. IN THIS CASE, THE IMPLANT COMPONENTS OVERLAPPED IN THE PLAN AND THUS TIGHTNESS WAS REFLECTED ON THE JOINT BALANCING GRAPH. A NEW FEATURE HAS BEEN IMPLEMENTED IN THE SOFTWARE TO ALLOW THE JOINT BALANCING PAGE TO BE USED AFTER RESECTION WITH TRIALS IN PLACE AS WELL AS DURING IMPLANT PLANNING. THE DISCREPANCY ON THE TIBIAL RESECTION WAS THE RESULT OF INADVERTENT MOVEMENT OF THE TIBIAL TRACKER.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED TWO PARTIAL KNEE ARTHROPLASTY CASES USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2011. AFTER INSTALLING THE BONE TRACKING ARRAYS INTO THE BONE, THE CAMERA COULD NOT DETECT THE ARRAYS; A HARD RESET REMEDIED THE ISSUE. DURING IMPLANT PLANNING, THE SURGEON OBSERVED THAT UPON ADJUSTING THE PLAN IN AN ATTEMPT TO LOOSEN THE JOINT, IT ACTUALLY APPEARED TO TIGHTEN ON THE GRAPH; AFTER ADJUSTING THE PLAN TO ENSURE THE IMPLANT COMPONENTS DID NOT OVERLAP, JOINT BALANCING WAS REPEATED WITH GOOD RESULTS. WHILE TRIALING THE TIBIA, THE SURGEON OBSERVED THAT THE CUT WAS FARTHER LATERAL AND DEEPER THAN PLANNED. THE SURGEON DETERMINED THAT THE PROPER COURSE OF ACTION WAS TO INCREASE THE COMPONENT SIZE BY ONE, DRILL PEG HOLES USING MANUAL INSTRUMENTATION. THE CASE WAS REPORTED TO BE SUCCESSFUL.

    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