BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER FEMORAL STEM

    MDR report key: 2041110 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00783
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    October 30, 2007
    Report Date
    March 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE STERILIZATION PROCESS FOR ALL DEVICES PRODUCED BY ZIMMER ARE VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER, AND ARE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MUST MEET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. IN ADDITION, BEFORE EACH MFG LOT IS RELEASED, THE "CERTIFICATE OF PROCESSING" FROM THE STERILIZATION SUPPLIER IS REVIEWED FOR CONFORMANCE. THIS CERTIFICATE LISTS THE MAXIMUM, MINIMUM AND ACTUAL GAMMA DOSE IN KGY. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE OF THE ALLEGED CONDITION CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO 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 TREATED FOR A LARGE HEMATOMA AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER FEMORAL STEM HIP PROSTHESIS KWY ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention