BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    MDR report key: 3537720 · Received October 24, 2013

    Report

    Report Number
    3005985723-2013-00085
    Event Type
    Malfunction
    Date Received
    October 24, 2013
    Date of Event
    September 24, 2013
    Report Date
    September 24, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT F/U, AN EVAL OF THE EVENT HAS BEEN CONDUCTED AT MAKO SURGICAL. THE DISCREPANT JOINT BALANCING VALUE WAS CAUSED BY A SHAFTED BONE TRACKING ARRAY. THIS IS A RISK OF NAVIGATED PROCEDURES, WHICH IS DOCUMENTED IN THE PRODUCT LITERATURE. THE ROOT CAUSE HAS BEEN COMMUNICATION TO THE MAKOPLASTY REP AT THE SITE TO PREVENT SIMILAR ISSUES IN FUTURE CASES.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING TRIALING, THE SURGEON STRUGGLED TO INSERT THE TRIALS. UPON TRIAL REDUCTION, THE SURGEON ENTERED THE JOINT BALANCING PAGE OF THE APPLICATION TO VERIFY RESULTS. IT WAS APPARENT DUE TO THE LOCATION OF THE FEMORAL COMPONENT MODEL, THAT A BONE TRACKING ARRAY HAD SHIFTED, AND CHECKPOINT VERIFICATION RESULTED IN A HIGH VALUE, CONFIRMING THE SHIFT. THE SURGEON CONTINUED BY REMOVING TRACKING INSTRUMENTATION AND CEMENTING THE IMPLANTS. GOOD JOINT STABILITY WAS OBSERVED AS THE SURGEON MOVED THE LEG THROUGH THE RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547512 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL 201000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR