BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA

    MDR report key: 3161554 · Received May 5, 2013

    Report

    Report Number
    3005985723-2013-00033
    Event Type
    Injury
    Date Received
    May 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K093425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVAL HAS BEEN INITIATED AT MAKO SURGICAL WITH REGARD TO THIS EVENT. NO PRELIMINARY RESULTS ARE CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A MAKOPLASTY TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). FORCEPS WERE USED AND THEN REMOVED WHILE PLACING THE ACETABULAR CHECKPOINT SCREW. IN THE ATTEMPT TO FINISH DRIVING THE CHECKPOINT INTO PLACE, IT SKIVED OFF POSTERIORLY AND WAS LOST BEHIND THE PELVIS. ANOTHER CHECKPOINT WAS OPENED AND PLACED TO KEEP THE CASE MOVING. AFTER THE CUP WAS IMPLANTED, A C-ARM WAS USED TO HELP LOCATE THE LOST CHECKPOINT. IN THE ATTEMPT TO RETRIEVE THE LOST CHECKPOINT, A VESSEL WAS RUPTURED AND A VASCULAR SURGEON WAS REQUIRED. AFTER TWO AND A HALF HOURS, THE SURGEON CHOSE TO LEAVE THE CHECKPOINT SCREW IN PATIENT. THE FEMORAL STEM WAS PLACED, AND THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196181 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 203999

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other RESTORIS PST TOTAL HIP IMPLANT