BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MCK MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 2644621 · Received June 27, 2012

    Report

    Report Number
    3005985723-2012-00176
    Event Type
    Injury
    Date Received
    June 27, 2012
    Date of Event
    May 28, 2012
    Report Date
    May 28, 2012
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT F/U, AN INVESTIGATION IS BEING PERFORMED AT MAKO SURGICAL WITH REGARDS TO THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC (RIO) AND RESTORIS MCK. THE INVESTIGATION IS CURRENTLY ONGOING WITH RESULTS PENDING COMPLETION OF THE INVESTIGATION. A SUBSEQUENT MDR WILL BE SUBMITTED IF RESULTS DEMONSTRATE THAT ROOT CAUSE OF THE EVENT IS DUE TO A MAKO DEVICE.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED AN ONLAY UNICOMPARTMENTAL PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MCK ON (B)(6) 2012. MAKO SURGICAL WAS MADE AWARE THAT THE SURGEON PERFORMED AN INCISION AND DRAINAGE PROCEDURE (KNOWN AS AN I & D) AND EXCHANGED THE RESTORIS MCK POLYETHYLENE COMPONENT ON (B)(6) 2012. ON (B)(6) 2012, A DIFFERENT SURGEON PERFORMED A REMOVAL OF PROSTHESIS W/INSERTION OF ANTIBIOTIC CEMENT SPACER DUE TO STAPH INFECTION ((B)(6)). THE SURGEON STATED THAT ONCE THE PT'S INFECTION CLEARS, HE WILL BE REVISED TO A TOTAL KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORIS MCK MULTICOMPARTMENTAL KNEE SYSTEM UNICONDYLAR KNEE NPJ MAKO SURGICAL 180706-1 12250911-2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention