BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3370369 · Received September 13, 2013

    Report

    Report Number
    3005985723-2013-00070
    Event Type
    Other
    Date Received
    September 13, 2013
    Date of Event
    July 13, 2011
    Report Date
    August 15, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT STATED THAT A CONSULTING SURGEON DID NOT RECOMMEND FURTHER SURGERIES DUE TO THE CHANCE OF HAVING FURTHER COMPLICATIONS. THE EVENT IS CURRENTLY UNDER INVESTIGATION AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED UPON DETERMINATION OF RESULTS.

    Description of Event or Problem · 1

    A PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, PERFORMED USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (MCK). MAKO WAS MADE AWARE VIA A PT SURVEY THAT THE PT IS EXPERIENCING PAIN AND SWELLING IN THE OPERATIVE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461293 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL 180612 26060211-01

    Patients

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