BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBONIT ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA

    MDR report key: 2382872 · Received November 30, 2011

    Report

    Report Number
    3005985723-2011-00050
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    October 24, 2011
    Report Date
    October 31, 2011
    Manufacturer
    MAKO SURGICAL
    Product Code
    OLO
    PMA / PMN Number
    K093425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP AN INVESTIGATION IS BEING PERFORMED AT MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO) - THA APPLICATION. THE INITIAL RESULTS OF THIS INVESTIGATION DEMONSTRATE THAT THE RIO-THA APPLICATION OPERATED AS INTENDED AND DESIGNED. THE SURGEON DID EXPRESS DISSATISFACTION WITH THE FEMORAL BROACH USED DURING THE PROCEDURE. THE FEMORAL BROACH IS PART OF CORIN LTD'S METAFIX HIP STEM WHICH IS COMPATIBLE WITH THE RIO-THA APPLICATION AND DISTRIBUTED BY MAKO SURGICAL CORP. FOR USE WITH THE RIO. THE FEEDBACK FROM THE SURGEON HAS BEEN LOGGED AS A COMPLAINT AND HAS BEEN FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. MAKO SURGICAL IS FILING THIS MDR TO ENSURE VISIBILITY TO AN ADVERSE EVENT THAT OCCURRED AS A RESULT OF A PROCEDURE THAT UTILIZED THE RIO-THA APPLICATION. IF THE RESULTS AFTER THE INVESTIGATION IS COMPLETE ARE DIFFERENT THAN DESCRIBED IN THIS REPORT, A FOLLOW-UP WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS SCHEDULED FOR A TOTAL HIP ARTHROPLASTY WITH THE ASSISTANCE OF THE MAKO ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) -THA. APPROXIMATELY 2 WEEKS POSTOPERATIVELY THE PATIENT WAS DIAGNOSED WITH A CALCAR FRACTURE (THE DENSE, VERTICALLY ORIENTATED BONE PRESENT IN THE POSTERO-MEDIAL REGION OF THE FEMORAL SHAFT UNDER THE LESSER TROCHANTER OF THE FEMUR). THE FRACTURE WAS ACCOMPANIED BY A DISLOCATION OF THE IMPLANTED FEMORAL HEAD FROM THE ACETABULAR CUP. THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL AND SURGEON FOR RE-EVALUATION AND POSSIBLY ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBONIT ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL 0201000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability CORIN TRINITY ACETABULAR SYSTEM| CORIN METAFIX HIP STEM