BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 1162271 · Received September 5, 2008

    Report

    Report Number
    1822565-2008-00578
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIBIAL INSERT BROKE UPON IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II SYSTEM CONGRUENT TIBIAL INSERT KNEE INSTRUMENT HSH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK