BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM KNEE

    MDR report key: 1193083 · Received October 2, 2008

    Report

    Report Number
    3005751028-2008-00023
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ZIMMER TMT
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    A RADIOGRAPHIC EVALUATION REVEALED THAT THE LOCKING KEY FOR THE TIBIAL BASEPLATE HAS PARTIALLY MIGRATED OUT. AT THE PRESENT TIME, NO REVISION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM KNEE PRIMARY TIBIAL COMPONENT HSH ZIMMER TMT 355382

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR