BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4268013 · Received November 12, 2014

    Report

    Report Number
    3005985723-2014-00189
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    KRR
    PMA / PMN Number
    K090763
    Product Problem
    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 WAS COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. PRIOR TO IMPLANTING THE TIBIAL BASEPLATE, THE SURGEON NOTICED THERE WAS RESIDUE ON THE TOP SURFACE OF THE IMPLANT. THE IMPLANT WAS NOT USED AND A NEW IMPLANT WAS USED. THIS EVENT DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728543 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS KRR MAKO SURGICAL 180602 26130214-01

    Patients

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