BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD PS OPEN BOX FEMORAL

    MDR report key: 1052084 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00138
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    July 9, 2007
    Report Date
    July 9, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Removal / Correction Number
    Z-123-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETERMINED THAT LABELS FOR LOT 395450 WERE REPRINTED AND LOT 395400 WAS SUBSEQUENTLY LABELED INCORRECTLY WITH THE PRINTED LABELS. 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 INITIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURE IN 2007. WRONG SIZED PRODUCT WAS FOUND INSIDE PACKAGE. PACKAGE WAS LABELED AS 183130, LOT 395450, SIZE 67.5MM, PRODUCT IN PACKAGE WAS MARKED WITH LOT 395400 SIZE 62.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD PS OPEN BOX FEMORAL JWH BIOMET, INC. NA 395450

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK