BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 8 -

    MDR report key: 2212945 · Received August 4, 2011

    Report

    Report Number
    3005751028-2011-00059
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K020295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. THE RECEIVED COMPLAINT STATES THE PT WAS REVISED DUE TO DEEP INFECTION FOR GREATER THAN 6 WEEKS. NO DEVICES OR LOT NUMBERS WERE PROVIDED WITH THE COMPLAINT FOR REVIEW. THEREFORE, NO DEVICE EVALUATION OR DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. 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. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. THE EVENT WAS EVALUATED BY THE SURGEON AND IT WAS DETERMINED THAT THE INFECTION WAS NOT CAUSED BY THE IMPLANT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO INFECTION. THE EVENT WAS EVALUATED BY THE SURGEON AND IT WAS DETERMINED THAT THE INFECTION WAS NOT CAUSED BY THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 8 - NONE JWH ZIMMER TMT 60984672

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention