BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRC PC FEM COM 4

    MDR report key: 144143 · Received January 9, 1998

    Report

    Report Number
    1038671-1998-00020
    Event Type
    Other
    Date Received
    January 9, 1998
    Date of Event
    December 15, 1997
    Report Date
    January 9, 1998
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON IMPLANTING BILATERAL KNEES USED AN IMPROPER COMBINATION OF FEMORAL COMPONENTS WITH TIBIAL INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRC PC FEM COM 4 Implant FEMORAL COMPONENTS HSA EXACTECH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other