BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRUCIATE RETAINING TIBIAL INSERT

    MDR report key: 1781397 · Received July 28, 2010

    Report

    Report Number
    1038671-2010-00095
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    April 15, 2010
    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 TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    REVISION OF KNEE ARTHROPLASTY 9 MONTHS POSTOPERATIVELY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRUCIATE RETAINING TIBIAL INSERT JWH EXACTECH, INC. 0410599

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R