BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 3802838 · Received May 2, 2014

    Report

    Report Number
    3005985723-2014-00053
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN PERFORMED BY MAKO SURGICAL. THE SURGEON STATED THAT THE OBSERVED MEDICAL OSTEOPHYTE OVERGROWTH WAS NEW OSTEOPHYTE THAT GREW IN AND WAS PROMINENT APPROXIMATELY 4-5 MM. THE SURGEON SAID THE OSTEOPHYTE ALSO RESULTED IN A GROOVE WORN IN THE PATELLA BUTTON COMPONENT. RIO SESSION FILES WERE ALSO REVIEWED, AND ALL VALUES WERE FOUND TO BE WITHIN ACCEPTABLE TOLERANCES. THERE IS NO EVIDENCE TO SUGGEST THAT THE RIO OR MCK IMPLANTS CONTRIBUTED TO THE PATIENT'S PHYSIOLOGICAL FACTORS THAT LED TO THE REQUIRED REVISION.

    Description of Event or Problem · 1

    A PATIENT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE IMPLANTS ON (B)(6) 2012. THE SURGEON PERFORMED A TOTAL KNEE REVISION ON THE DATE OF EVENT DUE TO MEDIAL CONDYLE OSTEOPHYTE OVERGROWTH ALONG THE ENTIRE MEDIAL CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263832 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS NPJ MAKO SURGICAL

    Patients

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