BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA

    MDR report key: 2839010 · Received November 8, 2012

    Report

    Report Number
    3005985723-2012-00222
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K093425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISION SURGERY TOOK PLACE APPROX FOUR AND A HALF MONTHS AFTER THE PRIMARY SURGERY. THE REVISION WAS DUE TO THE PT'S FALL AND IS NOT A DEFICIENCY OF ANY MAKO DEVICES. RIO SOFTWARE DOES NOT CONTROL ACETABULAR LINER COMPONENTS OR FEMORAL HEAD COMPONENTS.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). SOME TIME AFTER THE PROCEDURE, THE PT FELL AND COMPLAINED THAT HER HIP DID NOT FEEL AS STABLE AS BEFORE THE FALL. THE SURGEON REPLACED THE NEUTRAL ACETABULAR LINER AND REPLACED IT WITH AN EPW LINER. HE ALSO CHANGED THE SIZE 32 MM, -4 LENGTH FEMORAL HEAD TO A 32 MM, 0 LENGTH FEMORAL HEAD. THE PT IS RECOVERING WELL AND THE SURGEON SAID HE EXPECTS NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 203999

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention RESTORIS TRINITY TOTAL HIP IMPLANT