BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 44476 · Received October 25, 1996

    Report

    Report Number
    1644408-1996-00003
    Event Type
    Injury
    Date Received
    October 25, 1996
    Date of Event
    October 22, 1996
    Report Date
    October 25, 1996
    Manufacturer
    ENCORE ORTHOPAEDICS, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT 21 MONTHS POSTOP, PT MISSTEPPED AND FELL. PT DID NOT EXPERIENCE ANY DISCOMFORT. SURGEON X-RAYED THE AFFECTED JOINT AND THE X-RAY SHOWED THE TIBIAL INSERT ATTACHMENT SCREW WAS LOACTED POSTERIOR TO THE PROSTHESES. SURGEON HAS SCHEDULED REVISION SURGERY FOR 11/14/96 TO PRECLUDE ANY POTENTIAL ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM Implant TIBIAL INSERT ATTACHMENT SCREW HSH ENCORE ORTHOPAEDICS, INC. NA 48901/ATT.SCREW#RC05905

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention