BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISIONAL MODULAR HEAD FOR TOTAL HIP

    MDR report key: 114922 · Received August 22, 1997

    Report

    Report Number
    MW1011920
    Event Type
    Malfunction
    Date Received
    August 22, 1997
    Date of Event
    June 23, 1997
    Report Date
    August 22, 1997
    Manufacturer
    BIOMET INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SCREW CAME OFF OF PROVISIONAL HEAD AND WAS LEFT IN PT. MD BECAME AWARE TWO WEEKS LATER BY F/U X-RAY. PT IS AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISIONAL MODULAR HEAD FOR TOTAL HIP Implant PROSTHESIS LXH BIOMET INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO