BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRO

    MDR report key: 257620 · Received January 6, 2000

    Report

    Report Number
    1832656-1999-00006
    Event Type
    Malfunction
    Date Received
    January 6, 2000
    Date of Event
    September 28, 1999
    Report Date
    December 2, 1999
    Manufacturer
    BIOPRO, INC.
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FAILED TIBIAL COMPONENT. TIBIAL DISASSOCIATED FROM TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO TIBIAL POLY HSH BIOPRO, INC. NA M043070

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention