BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 145781 · Received January 19, 1998

    Report

    Report Number
    1123762-1998-00001
    Event Type
    Injury
    Date Received
    January 19, 1998
    Date of Event
    January 13, 1998
    Report Date
    January 15, 1998
    Manufacturer
    ZIMMER,INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN IBII CCK REVISION WAS DONE ON 8/22/96. FROM POST-OP X-RAY, ARTICULATING SURFACE AND LOCKING PIN APPEARED TO BE POSITIONED PROPERLY. REVISION SURGERY WAS DONE ON 1/13/98 BECAUSE TIBIAL ARTICULATING SURFACE HAD LIFTED OFF AND DISENGAGED FROM THE TIBIAL PLATE. LOCKING PIN WAS STILL INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant IBII TIBIAL PLATE HSH ZIMMER,INC. NA 74825200

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention