BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIAL ROTATION KNEE

    MDR report key: 5385068 · Received January 22, 2016

    Report

    Report Number
    3008985661-2016-00001
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    April 16, 2010
    Report Date
    January 22, 2016
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    PMA / PMN Number
    K020214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DEVICE UNATTENDED

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT OF HISTORICAL EVENT. THE EVENT OCCURED BETWEEN (B)(6) 2010 AND (B)(6) 2013 WHEN K020214 WAS NOT LISTED AGAINST ANY MANUFACTURER. MATORTHO IS MAKING THIS REPORT TO COVER THIS PERIOD WHEN THE DEVICE WAS NOT AVAILABLE IN THE USA FOR COMMERCIAL REASONS.

    Description of Event or Problem · 1

    REVISION OF MRK BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45549 MEDIAL ROTATION KNEE TOTAL KNEE REPLACEMENT JWH MATORTHO LIMITED NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention