BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NKI KNEE COMPONENT

    MDR report key: 6123251 · Received November 22, 2016

    Report

    Report Number
    0001822565-2016-04311
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO AN EVENT AND WAS NOT INVOLVED IN AN ADVERSE EVENT OR PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S SURGEON IS REQUESTING IMPLANTED PRODUCT IDENTIFICATION AND OPTIONS FOR A REVISION SURGERY DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771870 UNKNOWN NKI KNEE COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other