BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL JOINT PROSTHESIS, FEMORAL STEM

    MDR report key: 32200 · Received March 29, 1996

    Report

    Report Number
    32200
    Event Type
    Malfunction
    Date Received
    March 29, 1996
    Date of Event
    March 5, 1996
    Report Date
    March 5, 1996
    Manufacturer
    BIOPRO, INC.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BROKEN FEMORAL STEM, TOTAL STEM LENGTH = 8 1/4". STEM BROKEN HORIZONTALLY 4 1/2" FROM DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL JOINT PROSTHESIS, FEMORAL STEM Implant FEMORAL STEM KWY BIOPRO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR