BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROTHESIS

    MDR report key: 4092994 · Received September 5, 2014

    Report

    Report Number
    3005985723-2014-00126
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    KRR
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW UP, AN EVAL OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE EVAL IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INFO 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. DURING TIBIAL IMPACTION, THE TIP OF THE TIBIAL INSERT IMPACTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546408 RESTORIS MULTICOMPARTMENTAL KNEE PROTHESIS COMPARTMENTAL KNEE PROTHESIS, KRR, HSX, NPJ, HRY KRR MAKO SURGICAL

    Patients

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