BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM - RIO

    MDR report key: 2848075 · Received November 20, 2012

    Report

    Report Number
    3005985723-2012-00226
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K081867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF MAKO'S COMPLAINT HANDLING PROCESS, A COMPLAINT WAS INITIATED BY MAKO SURGICAL WITH REGARD TO THIS REPORT. THE INVESTIGATION IS ONGOING AND NO PRELIMINARY RESULTS ARE CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED AN ONLAY BICOMPARTMENTAL MAKOPLASTY PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2010. ON THE DATE OF EVENT, THE SURGEON PERFORMED A TOTAL KNEE REVISION DUE TO "LATERAL JOINT FAILURE WITH AVN (AVASCULAR NECROSIS) OF THE LATERAL FEMORAL CONDYLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM - RIO STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL 201000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability