BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    MDR report key: 3963922 · Received May 22, 2014

    Report

    Report Number
    3005985723-2014-00065
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE SURGEON STATED THAT THE POSTERIOR POST HOLE APPEARED TO HAVE BEEN RESECTED APPROXIMATELY 3-4 MM TOO FAR POSTERIORLY. THE SURGEON WAS ULTIMATELY SATISFIED WITH THE OUTCOME OF THE CASE. REVIEW OF THE CASE SESSION FILES FROM THE RIO SYSTEM USED IN THE PROCEDURE IS IN PROGRESS, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN RESULTS ARE OBTAINED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING IS A SUPPLEMENTAL REPORT TO THE ORIGINAL MDR SUBMITTED PREVIOUSLY. ADDITIONAL INFORMATION FROM THE EVENT'S INVESTIGATION IS PROVIDED HEREIN. THE ROOT CAUSE AT THIS TIME IS INCONCLUSIVE. THERE IS NO DATA TO SUGGEST AN ARRAY SHIFT AS DESCRIBED ABOVE. IT IS SUSPECTED THE SURGEON'S TECHNIQUE OF SLOW POST HOLE RESECTION CONTRIBUTED TO THE OBSERVED POST HOLE SHIFT. SLOW RESECTION COULD ALLOW FOR A LARGER THAN EXPECTED POST HOLE SIZE. THIS POSSIBLE LARGER THAN EXPECTED POST HOLE RESECTION COULD ALLOW FOR THE IMPLANT TO MOVE AROUND GIVING THE APPEARANCE THE IMPLANT HAD TRANSLATED. THIS INFORMATION WAS COMMUNICATED TO THE SURGEON'S MAKO REPRESENTATIVE IN AN EFFORT TO PREVENT FUTURE OCCURRENCES.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT SYSTEM. DURING FEMORAL IMPLANT TRIALING, THE SURGEON STATED THAT THE POSTERIOR POST HOLE APPEARED SHIFTED FROM PLAN AS COMPARED TO THE SURFACE RESECTION AND ANTERIOR POST HOLE. SYSTEM ACCURACY CHECKPOINTS WERE VERIFIED TO BE WITHIN TOLERANCE. THE SURGEON OPENED THE MCK MANUAL INSTRUMENTATION TRAY, AND DRILLED THE POSTERIOR POST HOLE. THE SURGEON VIEWED THE POST-OPERATIVE X-RAYS AND WAS SATISFIED WITH THE OUTCOME OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304524 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO STEREOTAXIC DEVICE OLO MAKO SURGICAL 204000

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR