BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIAL ROATION KNEE

    MDR report key: 5386284 · Received January 22, 2016

    Report

    Report Number
    3008985661-2016-00006
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    November 22, 2012
    Report Date
    January 22, 2016
    Manufacturer
    MATORHTO LIMITED
    Product Code
    JWH
    UDI-DI
    05055455503809
    PMA / PMN Number
    K020214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW CONFIRMED THAT THE DEVICE WAS CORRECTLY LABELED. REPORT OF HISTRIONICAL EVENT. THE EVENT OCCURED BETWEEN (B)(6) 2010 AND (B)(6) 2013 WHEN K020214 WAS NOT LISTED AGAINST A MANUFACTURER. MATORHTO 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

    PATIENT UNDERWENT SURGERY ON THE RIGHT KNEE. MATORTHO REPRESENTATIVE NOTED THAT THE PATIENT LABEL IN THE IMPLANT BOOK WAS FOR A LEFT TIBIAL INSERT. SURGEON WAS FAMILIAR WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43346 MEDIAL ROATION KNEE TOTAL KNEE REPLACEMENT JWH MATORHTO LIMITED 202361 05055455503809

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention