BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL INSERT

    MDR report key: 1843847 · Received September 21, 2010

    Report

    Report Number
    1038671-2010-00136
    Event Type
    Other
    Date Received
    September 21, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 21, 2010
    Manufacturer
    EXACTECH INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TIBIAL INSERT WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REVISION OF TOTAL KNEE ARTHROPLASTY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL INSERT JWH EXACTECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention