BEUDAMED
    FDA Adverse Event Other Summary report: N

    PSC FEM. COM. 3

    MDR report key: 126287 · Received October 15, 1997

    Report

    Report Number
    1038671-1997-00014
    Event Type
    Other
    Date Received
    October 15, 1997
    Date of Event
    September 10, 1997
    Report Date
    October 8, 1997
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SIZE 2 INSERT PLACED INTO A 3F/2T TRAY. THE INCORRECT SIZE WAS REMOVED AND THE CORRECT SIZE PLACED WITHOUT IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSC FEM. COM. 3 Implant FEMORAL COMPONENTS JWH EXACTECH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R