BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR CUP LINER

    MDR report key: 2060964 · Received March 14, 2011

    Report

    Report Number
    2648920-2011-00005
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    April 27, 2010
    Report Date
    May 24, 2010
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LINERS WERE MANUFACTURED APPROXIMATELY 2 YEARS APART BY DIFFERENT OPERATORS. THE INVENTORY FOR BOTH LOTS WAS FULLY DISTRIBUTED WITHOUT OTHER REPORTS OF THIS KIND. THERE IS NO WAY TO CONFIRM THAT THE FOREIGN MATTER WAS INSIDE THE PACKAGING PRIOR TO BEING OPENED. BOTH PACKAGES HAVE DRIED BLOOD INSIDE THE PACKAGES, WHICH IMPLIES THE ITEMS WERE OPENED AND PERHAPS EVEN ATTEMPTED TO BE USED. IT IS UNLIKELY THAT TWO SEPARATE LOTS WOULD BOTH HAVE CONTAMINANTS INSIDE THE PACKAGES DURING THE SAME PROCEDURE. THE STERILIZATION PROCESS 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 LOTS SPECIFIED WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. (B)(4). THEREFORE, IT IS HIGHLY UNLIKELY THAT THE PRESENCE OF THE FOREIGN MATERIAL FOUND IN THE PACKAGES WOULD LEAD TO INFECTIONS OR OTHER BIO-INCOMPATIBILITY IF THE DEVICES HAD BEEN IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND DEVIATIONS OR ANOMALIES. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A HAIR WAS FOUND IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPOLAR BIPOLAR CUP LINER JDI ZIMMER 60515279

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #61055657| MULTIPOLAR BIPOLAR CUP LINER: CATALOG #00500105028