BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTIM LSI TIBIAL INSERT

    MDR report key: 87312 · Received April 17, 1997

    Report

    Report Number
    1043534-1997-00042
    Event Type
    Injury
    Date Received
    April 17, 1997
    Date of Event
    March 14, 1997
    Report Date
    April 17, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COULD NOT RECEIVE EVENT DEVICE CODE FROM USER FACILITY UNTIL 08/05/1997.

    Description of Event or Problem · 1

    PAINFUL LEFT TOTAL KNEE ARTHROPLASTY POSSIBLY SECONDARY TO LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTIM LSI TIBIAL INSERT Implant KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA 073M889340

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention