BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIAL ROATION KNEE

    MDR report key: 5385145 · Received January 22, 2016

    Report

    Report Number
    3008985661-2016-00005
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    November 12, 2012
    Report Date
    January 22, 2016
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    PMA / PMN Number
    K020214
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT OF HISTORIC EVENT. THE EVENT OCCURED BETWEEN (B)(6) 2010 AND (B)(6) 2013 WHEN K020214 WAS NOT LISTED AGAINST A MANUFACTURER. MATORTHO IS MAKING THIS REPORT TO COVER THIS PERION WHEN THE DEVICE WAS NOT AVAILABLE INT HE USA FOR COMMERCIAL REASONS.

    Description of Event or Problem · 1

    PIN INSERTER/EXTRACTOR PART NUMBER 231-304 BROKE WHEN STRUCK WITH A HAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45151 MEDIAL ROATION KNEE TOTAL KNEE REPLACEMENT INSTRUMENT JWH MATORTHO LIMITED F90676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention