BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 3683311 · Received February 28, 2014

    Report

    Report Number
    3005985723-2014-00016
    Event Type
    Other
    Date Received
    February 28, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT F/U, AN EVAL OF THE EVENT HAS BEEN CONDUCTED BY MAKO SURGICAL. ACCORDING TO THE SURGEON, THE ORIGINAL MEDIAL IMPLANT COMPONENTS ARE PLACED WELL, WITH NO LOOSENING NOTED. REMOVAL OF AN ONLAY TIBIAL INSERT TYPICALLY WILL DAMAGE THE INSERT, SO IN ORDER TO EVALUATE THE FEMORAL AND TIBIAL BASEPLATE COMPONENTS, THE SURGEON REPLACED THE ONLAY TIBIAL INSERT COMPONENT ONLY. THE RIO SESSION FILES WERE ALSO REVIEWED AND ALL VALUES WERE WITHIN ACCEPTABLE TOLERANCES. THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST THAT THE MCK IMPLANTS NOR THE PLACEMENT OF THE IMPLANTS SUPPORTED BY THE RIO, ARE CONTRIBUTING TO THE PT'S PAIN.

    Description of Event or Problem · 1

    A PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, WHICH WAS PERFORMED USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE IMPLANTS. MORE THAN SIX MONTHS AFTER THE PROCEDURE, THE PT PRESENTED WITH PAIN DURING WEIGHT BEARING. THE SURGEON PERFORMED AN OPEN EVAL OF THE IMPLANTS. THE SURGEON REMOVED THE TIBIAL ONLAY INSERT COMPONENT IN ORDER TO EVALUATE THE FEMORAL AND TIBIAL BASEPLATE COMPONENTS. THE SURGEON COULD NOT IDENTIFY ANY ISSUES WITH EITHER THE METAL COMPONENTS OR THE INSERT; HE REPLACED THE INSERT WITH A NEW STERILE INSERT OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124907 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS NPJ MAKO SURGICAL 180702-1 12170113-1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)