BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 3881188 · Received February 11, 2014

    Report

    Report Number
    3005985723-2014-00008
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K121064
    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 OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER THE ACETABULAR CUP AND LINER WERE IMPLANTED, THE SURGEON WAS TRIALING THE FEMORAL STEM AND HEAD. AFTER REDUCING THE JOINT, THE SURGEON RECORDED A CHECKPOINT, AND THE RIO DISPLAYED THE LEG WAS TRIALING THE FEMORAL STEM AND HEAD. AFTER REDUCING THE JOINT, THE SURGEON RECORDING A CHECKPOINT, AND THE RIO DISPLAYED THE LEG WAS LONGER THAN PLANNED. THE SURGEON WENT AHEAD THE IMPLANTED THE FINAL STEM AND HEAD, AND REDUCED, AND THE SAME LEG LENGTH RESULT WAS MEASURED BY THE RIO. THE SURGEON PERFORMED A MANUAL ASSESSMENT OF THE PATIENT'S LEG LENGTH AND CONFIRMED THE RESULT WAS AS HE ORIGINALLY PLANNED. THE CASE CONCLUDED WITH A REPORTED SUCCESSFUL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90100 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTACTIC DEVICE OLO MAKO SURGICAL 204000

    Patients

    Seq Age Sex Outcome Treatment
    1 RESTORIS PST TOTAL HIP SYSTEM