BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    MDR report key: 6061960 · Received October 27, 2016

    Report

    Report Number
    0002648920-2016-03228
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 13, 2016
    Report Date
    January 31, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE DEVICE WAS PREVIOUSLY INVESTIGATED ON MEDWATCH# :0001822565-2016-01955. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713139 NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT KNEE, PROSTHESIS JWH ZIMMER MANUFACTURING B.V. N/A 62768860

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR