BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COONRAD/MORREY HUMERAL COMPONENT

    MDR report key: 1884562 · Received October 19, 2010

    Report

    Report Number
    1822565-2010-00906
    Event Type
    Injury
    Date Received
    October 19, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: STERILIZATION PROCESSES FOR ZIMMER DEVICES ARE VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. IN ADDITION, BEFORE EACH MANUFACTURING LOT IS RELEASED, THE "CERTIFICATE OF PROCESSING" FROM (B)(4) (STERILIZATION SUPPLIER) IS REVIEWED FOR CONFORMANCE. THIS CERTIFICATE LISTS THE MAXIMUM, MINIMUM, AND ACTUAL GAMMA DOSE IN KGY. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE PT INFECTION. DUE TO INSUFFICIENT INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR BUSHING WEAR AND INFECTION. DEVICES WERE IMPLANTED FOR 12.45 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK COONRAD/MORREY HUMERAL COMPONENT ELBOW PROSTHESIS JDC ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention CATALOG # UNK| UNK COONRAD/MORREY ULNAR COMPONENT, LOT # UNK,