BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM - RIO

    MDR report key: 2574533 · Received May 7, 2012

    Report

    Report Number
    3005985723-2012-00123
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    November 9, 2011
    Report Date
    April 24, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 SYSTEM (RIO). THE CT IMAGES WERE REVIEWED AND IT WAS OBSERVED THAT THE IMAGE WAS NOT ACCURATE AND RESULTED IN A 3D BONE MODEL WITH MANY VISUAL ARTIFACTS SUCH AS SMALL "SPIKES" THAT DID NOT STAY TRUE TO THE CT BONE SURFACE. THOUGH NO ISSUE WITH BONE REGISTRATION WAS REPORTED, THE BONE REGISTRATION POINTS WERE CLUSTERED AND NOT COLLECTED ACCORDING TO THE PRESCRIBED PATTERN, WHICH LIKELY CONTRIBUTED TO HIGH ROTATION VALUES OBSERVED DURING JOINT BALANCING.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2011. AFTER TRIALING THE FEMUR AND TIBIA, THE SURGEON OBSERVED THAT THE COMPONENTS APPEARED TO BE TRACKING FURTHER LATERALLY THAN PLANNED AND THE JOINT APPEARED TO BE TIGHTER THAN PLANNED. THE SURGEON AGREED TO RESECT MORE BONE AFTER MODIFYING THE PLAN TO SEAT THE TIBIA COMPONENT DEEPER BY 1 MM. UPON TRIALING, THE SURGEON NOTED THAT THE JOIN LAXITY HAD IMPROVED, AND HE IMPLANTED THE COMPONENTS. THE SURGEON INSPECTED THE IMPLANT TRACKING VISUALLY, AND STILL FELT THEY WERE TRACKING SLIGHTLY LATERALLY.

    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