BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 2121997 · Received May 24, 2011

    Report

    Report Number
    1822565-2011-01214
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED NO PARTICULATE CAN BE FOUND ON THE DEVICES. THE STERILIZATION PROCESS FOR THESE DEVICES WERE VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER. THE MANUFACTURING LOTS SPECIFIED IN THIS COMPLAINT WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. ADDITIONALLY, THESE DEVICES WERE PACKAGED IN A CLASS 10,000 CLEAN ROOM , UNDER A SPECIALLY DESIGNED HOODED PACKAGING STATION THAT CREATES A CLASS 1000 CLEAN ROOM ENVIRONMENT THAT SIGNIFICANTLY REDUCES THE PRESENCE OF FOREIGN CONTAMINANTS. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE PRESENCE OF THE FOREIGN MATERIAL WOULD LEAD TO ANY INFECTIONS OR OTHER BIO-INCOMPATIBILITY IF THE DEVICE HAD BEEN USED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON NOTICED DEBRIS ON THE UNDER SURFACE OF THE BASEPLATE. A DIFFERENT BASEPLATE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 61643908

    Patients

    Seq Age Sex Outcome Treatment
    1