BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3535812 · Received November 20, 2013

    Report

    Report Number
    3005985723-2013-00089
    Event Type
    Other
    Date Received
    November 20, 2013
    Date of Event
    October 2, 2013
    Report Date
    October 2, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    JWH
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CLAIMED THAT SHE HAS HAD AN ADDITIONAL X-RAY, WHICH INDICATED POSSIBLE BURSITIS. IT IS UNKNOWN AT THIS TIME WHETHER ROOT CAUSE IS RELATED TO THE MCK IMPLANT SYSTEM AND IS CONTRIBUTING TO THE CONDITION. THE RIO'S SYSTEM FILES FROM THE ORIGINAL MAKOPLASTY SURGERY WERE ALSO REVIEWED AS PART OF THE COMPLAINT EVALUATION. ALL VALUES WERE FOUND TO BE WITHIN ACCEPTABLE TOLERANCES. NO MALFUNCTION COULD BE FOUND AND IT WAS THEREFORE CONCLUDED THAT THE RIO SYSTEM PERFORMED AS INTENDED. CLINICAL INVESTIGATION OF THE EVENT REPORT IS ONGOING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE PT HAD RECEIVED A PARTIAL KNEE ARTHROPLASTY, PERFORMED USING MAKO'S ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (MCK). EIGHT WEEKS POST-OPERATIVELY, PT IS STILL IN PAIN. SHE SAYS SHE IS STILL DOING PT, HAS TOTAL MOTION OF HER KNEE, IS TAKING ANTI-INFLAMMATORIES AND HAS HAD A TOREDAL INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604376 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM JWH MAKO SURGICAL

    Patients

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