BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 2571007 · Received May 7, 2012

    Report

    Report Number
    3005985723-2012-00131
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    February 17, 2012
    Report Date
    April 24, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT F/U AN EVALUATION WAS PERFORMED BY MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO). THE RESULTS OF THE EVALUATION REVEALED THAT THE LIKELY CAUSE OF THIS ISSUE IS INADVERTENT MOVEMENT OF THE FEMORAL TRACKING ARRAY DURING THE PROCEDURE, WHICH IS A RISK DOCUMENTED IN THE APPLICATION USER GUIDE. THE RESULTS OF THE EVALUATION WERE COMMUNICATED TO THE SURGEON AND MPS TO ENSURE PROPER TECHNIQUE IS FOLLOWED.

    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) 2012. AFTER BURRING THE FEMUR, THE SURGEON NOTED THAT THE FEMORAL PEG HOLES APPEARED TO BE OFF-CENTER. THE MAKOPLASTY SPECIALIST (MPS) PRESENT AT THE CASE AIDED THE SURGEON IN REVIEWING THE IMPLANT PLAN AND PERFORMING ACCURACY CHECKS. THE SURGEON WAS SATISFIED THAT THE PLAN WAS CORRECT, AND PROCEEDED TO IMPLANT THE COMPONENTS.

    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