BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIAL ROTATION KNEE

    MDR report key: 5385130 · Received January 22, 2016

    Report

    Report Number
    3008985661-2016-00002
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    April 1, 2011
    Report Date
    January 22, 2016
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    UDI-DI
    05055455503854
    PMA / PMN Number
    K020214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEWED AND LABELS CONFIRMED AS CORRECT. ERROR AT HOSPITAL. 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 AVAIALBLE IN THE USA FOR COMMERCIAL REASONS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT. FOLLOWING SURGERY, THE SCRUB NURSE IDENTIFIED THAT A RIGHT TIBIAL INSERT HAD BEEN USED, NOT A LEFT TIBIAL INSERT. PATIENT WAS INFORMED AND REVISED 1 DAY POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45244 MEDIAL ROTATION KNEE TOTAL KNEE REPLACEMENT JWH MATORTHO LIMITED 98334 05055455503854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention