BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2885082 · Received December 11, 2012

    Report

    Report Number
    3005985723-2012-00232
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    HAW
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. NO PRELIMINARY RESULTS ARE CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2011. ON THE DATE OF THIS REPORT, MAKO WAS INFORMED THAT THE SURGEON PERFORMED A TOTAL KNEE REVISION. THE SURGEON NOTED THAT THE TIBIAL BASEPLATE COMPONENT WAS LOOSE AND APPEARED TO BE COMPACTED INTO THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENT KNEE PROSTHESIS SYSTEM HAW MAKO SURGICAL 180613 26200411-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability