BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IUNI G2

    MDR report key: 6028302 · Received October 13, 2016

    Report

    Report Number
    3004153240-2016-00198
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 1, 2016
    Report Date
    November 9, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    HSX
    UDI-DI
    M572UKA1111111031
    PMA / PMN Number
    K092441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE THICKER SIZED POLY INSERT PROVIDED WITH THE KIT WOULD NOT FIT INTO THE TIBIAL TRAY. THE SURGEON USED THE THINNER SIZED POLY INSERT PROVIDED WITH THE KIT. SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE THICKER SIZED POLY INSERT PROVIDED WITH THE KIT WOULD NOT FIT INTO THE TIBIAL TRAY. THE SURGEON USED THE THINNER SIZED POLY INSERT PROVIDED WITH THE KIT. SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE DEVICE WAS MANUFACTURED TO SPECIFICATION. RETURNED DEVICE EVALUATION: THE THICKER SIZED POLY INSERT AND ADDITIONAL UNUSED THINNER SIZED POLY INSERT WERE RETURNED FOR EVALUATION. REVIEW INDICATES THAT THE INSERTS WERE MANUFACTURED TO SPECIFICATION. SOME SCRATCHES WERE OBSERVED ON THE THICKER POLY INSERT. THE POSTERIOR AND ANTERIOR INTERLOCKS WERE UNDAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THICKER SIZED POLY INSERT PROVIDED WITH THE KIT WOULD NOT FIT INTO THE TIBIAL TRAY. THE SURGEON USED THE THINNER SIZED POLY INSERT PROVIDED WITH THE KIT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677630 IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM HSX CONFORMIS, INC. M572UKA1111111031

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR