BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4298263 · Received November 21, 2014

    Report

    Report Number
    3005985723-2014-00192
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 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 HAS BEEN INITIATED AT MAKO SURGICAL. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN FURTHER INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. WHEN THE SURGEON WAS TRIALING, HE INSERTED THE FEMORAL TRIAL INSERTER INSTRUMENT INTO THE FEMORAL TRIAL. WHEN HE DID THIS, THE INSERTER TIP SHEARED OFF INSIDE OF THE FEMORAL TRIAL. ANOTHER INSTRUMENT TRAY WAS OPENED AND THE BREAKAGE DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758217 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS, KRR, HSX, NPJ, HRY KRR MAKO SURGICAL 111140 06040711

    Patients

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