BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 98765 · Received June 18, 1997

    Report

    Report Number
    1644408-1997-00004
    Event Type
    Injury
    Date Received
    June 18, 1997
    Date of Event
    June 11, 1997
    Report Date
    June 18, 1997
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT, AT 14 MONTHS POSTOP EXPERIENCED PAIN. X-RAY SHOWED THE TIBIAL INSERT ATTACHMENT SCREW WAS NOT ENGAGED. REVISION SURGERY ON 6/11/97. TIBIAL INSERT WAS STILL LOCKED INTO THE TIBIAL BASEPLATE. THE ATTACHMENT SCREW HAD MIGRATED TO THE AREA AROUND THE MEDIAL FEMORAL CONDYLE. THE SURGEON REPLACED THE TIBIAL INSERT ONLY -- HE DETERMINED THAT THE FEMORAL COMPONENT WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM Implant STEMMED TIBIAL BASEPLATE AND TIBIAL INSERT HSH ENCORE ORTHOPEDICS, INC. * 110891 & 83771

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention