BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTILE GUIDANCE SYSTEM V. 2.0

    MDR report key: 2068226 · Received April 13, 2011

    Report

    Report Number
    3005985723-2011-00009
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 8, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE SYSTEM DID NOT INDICATE ANY MALFUNCTION REGARDING THE PERFORMANCE OF EITHER THE SOFTWARE OR HARDWARE DURING THE PROCEDURE. PER COMPLAINT (B)(4), THE SURGEON DID NOT FOLLOW THE COMPLETE RECOMMENDED SURGICAL TECHNIQUE, FAILING TO REMOVE THE PROUD BONE AND CARTILAGE TISSUES AFTER COMPLETION OF BONE PREP, AND SLIGHTLY UNDER-SIZING THE PATELLOFEMORAL COMPONENT. BASED ON ALL ANALYSES, THE SYSTEM WAS FUNCTIONING AS DESIGNED WITHOUT ERROR, AND THE CT VIEW INFORMATION WAS DISPLAYED TO THE SURGEON CORRECTLY, BUT MISINTERPRETED. THE DEPARTURE FROM THE RECOMMENDED TECHNIQUE, COMBINED WITH THE MISINTERPRETATION OF THE CT VIEW DATA, CONTRIBUTED TO THE SURGEON'S PERCEPTION THAT THE PF IMPLANT WAS TOO DEEP, AND HIS SUBSEQUENT CONVERSION OF THE CASE TO A TOTAL KNEE ARTHROPLASTY.

    Description of Event or Problem · 1

    TKA CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACTILE GUIDANCE SYSTEM V. 2.0 STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 0201000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR