BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS N-K FLEX ARTICULAR SURFACE

    MDR report key: 2860464 · Received December 5, 2012

    Report

    Report Number
    1822565-2012-02468
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    August 14, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WAS REPORTED THAT THE PATIENT'S KNEE WAS STIFF. SCAR TISSUE WAS REMOVED AND THE KNEE WAS CLEANED OUT. A POLYETHYLENE EXCHANGE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTIONS N-K FLEX ARTICULAR SURFACE MBH ZIMMER, INC. 61858924

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention