BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 3229534 · Received July 12, 2013

    Report

    Report Number
    1822565-2013-01103
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER EXPECTS THAT ALL PRODUCT LABELED WITH AN EXPIRATION DATE WILL NOT BE USED PAST THE STATED EXPIRATION DATE; HOWEVER, PACKAGING STERILITY IS CONSIDERED TO BE EVENT RELATED, NOT "TIME RELATED." PACKAGED METALS ARE CONSIDERED TO REMAIN STERILE UNLESS THE STERILE BARRIER HAS BEEN DAMAGED OR OTHERWISE COMPROMISED. ASSUMING THAT THE PACKAGING MATERIAL WAS INTACT FOR THE PRODUCT INVOLVED IN THIS COMPLAINT, THE RISK TO THE PATIENT IS LIKELY MINIMAL. EVALUATION CODES: THE PACKAGING LABEL SHEET FOR THE SPECIFIED DEVICE WAS REVIEWED FROM DEVICE HISTORY RECORDS AND THE EXPIRATION DATE OF 06/2012 WAS VERIFIED. THE TERRITORY PROVIDED THE IMPLANT USAGE SHEET WHICH ALSO CLEARLY SHOWS THE EXPIRATION DATE SPECIFIED AS 06/2012 ON THE PATIENT CHART STICKER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPLANTED TIBIAL BASEPLATE HAD EXCEEDED ITS EXPIRATION DATE. THIS ISSUE WAS NOT REALIZED UNTIL 2 WEEKS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323751 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 60720413

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR