BEUDAMED
    FDA Adverse Event Other Summary report: N

    PS TIBIAL INSERT

    MDR report key: 1781403 · Received July 28, 2010

    Report

    Report Number
    1038671-2010-00112
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    August 1, 2009
    Report Date
    July 28, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR MFR'S EVAL.

    Description of Event or Problem · 1

    REVISION OF TOTAL KNEE ARTHROPLASTY 7 MONTHS POSTOPERATIVELY DUE TO CONTINUED PAIN AND DISCOMFORT. PT WAS REVISED TO SMALLER FEMORAL AND TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS TIBIAL INSERT JWH EXACTECH, INC. 1196035

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R