BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGC INTLK MOLDED TIBIAL

    MDR report key: 1052087 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00141
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    July 24, 2007
    Report Date
    July 24, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K921182
    Removal / Correction Number
    Z-076/077-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF RETURNED DEVICE, DISTRIBUTION TRANSACTIONS AND RECOVERED INVENTORY DETERMINED THAT ONE (1) UNIT FROM EACH LOT WAS INTERCHANGED DURING PRODUCTION AND SUBSEQUENTLY, CONDITION REMAINED UNDETECTED AND MIXED UNITS WERE INCORRECTLY LABELED. CORRECTIVE AND PREVENTIVE ACTIONS WERE INITIATED. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED; EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED. THIS REPORT FILED ON MAY 20, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING KNEE PROCEDURE IN 2007, PACKAGE LOT 311500, 12MM X 80MM WAS OPENED AND CONTAINED ITEM, LOT 918930, 18MM X 65MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC INTLK MOLDED TIBIAL JWH BIOMET, INC. NA 311500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK