BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2680933 · Received July 27, 2012

    Report

    Report Number
    3005985723-2012-00184
    Event Type
    Injury
    Date Received
    July 27, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP AN INVESTIGATION WAS PERFORMED AT MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO) AND RESTORIS MCK. THE SURGEON CHOSE TO EXCHANGE THE TIBIAL INSERT POLYETHYLENE COMPONENT DURING THE ROUTINE PROCEDURE AS A PRECAUTIONARY MEASURE SINCE THE JOINT WAS ALREADY EXPOSED. THERE WAS NO EVIDENCE THAT THE RIO OR RESTORIS MCK IMPLANT SYSTEM CAUSED OR CONTRIBUTED TO THE NEED FOR THE EXCHANGE OF THE POLYETHYLENE COMPONENT.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) ON (B)(6) 2011. MORE THAN SIX MONTHS AFTER THE PROCEDURE, ON (B)(6) 2012, THE SURGEON ELECTED TO PERFORM AN INCISION AND DRAINAGE PROCEDURE (KNOWN AS AN I&D) AND EXCHANGED THE RESTORIS MCK TIBIAL INSERT POLYETHYLENE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 180707-1 12200511-2

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)