BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIAL ROTATION KNEE

    MDR report key: 5385133 · Received January 22, 2016

    Report

    Report Number
    3008985661-2016-00003
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    May 22, 2012
    Report Date
    January 22, 2016
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    UDI-DI
    05055455503465
    PMA / PMN Number
    K020214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED THAT THE OUTER STERILE BARRIER WAS DAMAGED BUT UNABLE TO EVALUATE WHEN THIS DAMAGE OCCURED DUE TO POOR HANDLING ON RECEIPT. 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

    DAMAGE NOTICED TO OUTER STERILE BARRIER PACKAGING. IDENTIFIED PRIOR TO USE AND ALTERNATIVE DEVICE AVAILABLE FOR IMMEDIATE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44542 MEDIAL ROTATION KNEE TOTOAL KNEE REPLACEMENT JWH MATORTHO LIMITED 200874 05055455503465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention