BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO SURGICAL CORP

    MDR report key: 2057536 · Received April 8, 2011

    Report

    Report Number
    MW5020228
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    August 9, 2010
    Report Date
    April 8, 2011
    Product Code
    OLO
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2010, I HAD A KNEE SURGERY LEFT LEG USING THE MAKOPLASTY ROBIC ARM. ALL I KNOW IS THE LIGHT WENT OUT AND COMPUTER PARTS BROKE DOWN AND COULD NOT BE BOOTED BACK UP. ONE AND HALF HOUR SURGERY TURNED INTO FOUR HOURS FREE HANDED BY DR. (B)(6). ON (B)(6) HE TOLD ME HEALING WAS COMPRISED BY ARM MALFUNCTION. ON (B)(6), 2010 WAS TOLD IT WAS A FAILED PROCEDURE BUT DO TWO MORE MONTHS OF THERAPY AND I AGREED. TO THIS DAY MY QUAD MUSCLES DO NOT FUNCTION AND I WALK WITH A CANE, CANNOT WORK BECAUSE I CANNOT STOOP OR KNEEL AND SOMETIMES I FALL DUE TO BALANCE. SOMETHING NEEDS TO BE DONE ABOUT THIS ISSUE, LIKE BACK UP SYSTEMS OR GO THE OLD FASHION WAY; THEIR HAND. VERY ANGRY AND UPSET BECAUSE I CANNOT GET A CORRECT ANSWER, ABOUT WHAT HAPPENED MAKOPLASTY TOLD ME TO ASK DOCTOR, DOCTOR SAID LIGHT WENT OUT, THAT'S ABOUT IT. COMPANY DID CALL ME THREE WEEKS LATER BUT REALLY DID NOT CARE. KEEP SAYING ASK DOCTOR. (B)(6) HOSPITAL (B)(6). MAKOPLASTY ROBIC ARM (B)(6) 2010 THERAPY WENT TO 40 VISIT OUT OF 49.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAKO SURGICAL CORP RIO ROBIC ARM OLO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R