BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR CUP LINER

    MDR report key: 2802578 · Received October 19, 2012

    Report

    Report Number
    2648920-2012-00223
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ZIMMER
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. PERSONNEL IN THE CLEAN ROOM ARE REQUIRED TO WEAR ITEMS SUCH AS HAIR NETS, PROTECTIVE CLOTHING AND BOOTIES, TO REDUCE THE LIKELIHOOD OF FOREIGN MATERIALS FROM BEING INTRODUCED DURING THE PACKAGING PROCESS. THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THE MFG LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. RETURNED FOR REVIEW IS A MULTIPOLAR LINER. NO PACKAGING IS RETURNED FOR REVIEW. AS RETURNED, THERE IS NO EVIDENCE OF THE BLACK SPEC ON THE LINER BECAUSE IT HAD WASHED AWAY DURING CLEANING. A POOR RESOLUTION PICTURE WAS SUBMITTED, WHICH SHOWS A BLACK SPOT ON THE CONCAVE SURFACE OF THE LINER, HOWEVER, ITS ORIGIN IS NOT ABLE TO BE DISCERNED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPLANT HAD A BLACK SPECK INSIDE IT WHEN IT WAS OPENED. THE BLACK SPECK THEN FELL OUT ONCE THE IMPLANT WAS CLEANED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPOLAR BIPOLAR CUP LINER KWY ZIMMER 62143883

    Patients

    Seq Age Sex Outcome Treatment
    1