BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK TIBIA LPS SIZE: NBR 4-

    MDR report key: 1972255 · Received January 21, 2011

    Report

    Report Number
    3005751028-2011-00001
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 21, 2011
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K020295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS. AT THE PRESENT, LIMITED INFORMATION IS AVAILABLE TO FURTHER THIS INVESTIGATION. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    EVENT DETAIL: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A SUBSIDED TIBIA. THE SURGEON STATED THAT THE PATIENT HAS A HISTORY AS A CHRONIC NARCOTIC USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN TM MONOBLOCK TIBIA LPS SIZE: NBR 4- NONE JWH ZIMMER TMT 56461548

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention