BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MCK MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2659493 · Received July 6, 2012

    Report

    Report Number
    3005985723-2012-00178
    Event Type
    Injury
    Date Received
    July 6, 2012
    Date of Event
    June 7, 2012
    Report Date
    June 7, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 POLY COMPONENT DURING THE ROUTINE PROCEDURE AS A PRECAUTIONARY MEASURE SINCE THE JOINT WAS ALREADY EXPOSED. THERE WAS NO EVIDENCE THAT THE RIO OR IMPLANT SYSTEM CAUSED OR CONTRIBUTED TO THE NEED FOR THE RESTORIS MCK TIBIAL INSERT POLYETHYLENE COMPONENT SWAP.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A UNICONDYLAR PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). MAKO SURGICAL WAS MADE AWARE ON (B)(6) 2012, THAT 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 MCK MULTICOMPARTMENTAL KNEE SYSTEM UNICONDYLAR KNEE NPJ MAKO SURGICAL 180705-1 12181011-2

    Patients

    Seq Age Sex Outcome Treatment
    1