BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROLONG ALL-POLY PATELLA

    MDR report key: 4801803 · Received May 26, 2015

    Report

    Report Number
    2648920-2015-00184
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Report Date
    April 23, 2015
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. VISUAL EXAMINATION OF THE RECEIVED PRODUCT FOUND NO FOREIGN MATERIAL AS REPORTED. THE PATELLA COMPONENT WAS DIMENSIONALLY IN SPECIFICATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FINDING NO DEVIATIONS OR ANOMALIES. THIS DEVICE WAS 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. THE STERILIZATION PROCESS FOR THIS DEVICE WAS 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 LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATELLA COMPONENT WAS OPENED AND THE FOIL PACKAGE TOP WAS REMOVED, A DARK FLECK WAS NOTICED ON THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340786 NEXGEN PROLONG ALL-POLY PATELLA JWH ZIMMER 62961941

    Patients

    Seq Age Sex Outcome Treatment
    1