BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE POSTERIOR STABILIZED TIBIAL INSERT

    MDR report key: 53388 · Received November 21, 1996

    Report

    Report Number
    53388
    Event Type
    Injury
    Date Received
    November 21, 1996
    Date of Event
    October 22, 1996
    Report Date
    November 21, 1996
    Manufacturer
    WRIGHT MEDIAL TECHNOLOGY, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL KNEE DONE 8/27/96, WITH A CO'S PROSTHESIS. TIBIAL PART HAD ALLEGEDLY DISPLACED. REVISION LTK 10/22/96. PT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE POSTERIOR STABILIZED TIBIAL INSERT Implant KNEE COMPONENT-DEVICE 1 JWH WRIGHT MEDIAL TECHNOLOGY, INC. NA 046A045109

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention