BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRC PC FEM. COM. 4

    MDR report key: 48358 · Received November 8, 1996

    Report

    Report Number
    1038671-1996-00003
    Event Type
    Other
    Date Received
    November 8, 1996
    Date of Event
    June 10, 1996
    Report Date
    November 4, 1996
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REVISION (OF LEFT KNEE) DUE TO POSTOPERATIVE INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention