BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 117852 · Received September 3, 1997

    Report

    Report Number
    53208-1997-00001
    Event Type
    Injury
    Date Received
    September 3, 1997
    Date of Event
    July 30, 1997
    Report Date
    September 3, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN OPENING THE PATIENT, AN OPENING WAS NOTED THAT WENT FROM THE OUTSIDE OF THE TIBIA TO THE DISTAL END OF THE STEM EXTENSION. ONCE THE TIBIA PROSTHESIS AND STEM EXTENSION WERE REMOVED, IT WAS NOTED THAT THE EXTENSION WAS LOOSE FROM TEH TIBIAL PLATE AND DR. FELT THIS WAS THE POINT OF THE BEGINNING OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant MGII HSH ZIMMER, INC. STEM TIBIA SIZE G 52239200

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 5782 076 STEM EXTENSION LOT #53538000