BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 3964137 · Received July 11, 2014

    Report

    Report Number
    3005985723-2014-00091
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. AN ONLAY TIBIAL INSERT EXCHANGE IS ROUTINE PROCEDURE FOR WOUNDS THAT APPEAR INFLAMED OR ARE INFECTED AFTER SURGERY. AT THIS TIME, NO MAKO IMPLANT COMPONENT HAS BEEN KNOWN TO HAVE CONTRIBUTED TO POST-OPERATIVE INFLAMMATION OR INFECTION. FURTHER EVALUATION IN ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFO IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. APPROXIMATELY SIX WEEKS AFTER SURGERY, THE PT WAS TREATED FOR INFECTION, AND THE ONLAY TIBIAL INSERT COMPONENT WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407595 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS NPJ MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO)