BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMER ADVANTIM POST STAB LSI TIBIAL INSERT

    MDR report key: 91898 · Received May 14, 1997

    Report

    Report Number
    1043534-1997-00057
    Event Type
    Injury
    Date Received
    May 14, 1997
    Date of Event
    April 1, 1997
    Report Date
    May 13, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRP
    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

    INVESTIGATION IS NOT COMPLETE. EVENT DEVICE CODE NOT REC'D UNTIL 08/05/1997.

    Description of Event or Problem · 1

    PAINFUL LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO LOOSE FEMORAL AND TIBIAL COMPONENTS. DISRUPTION EXTENSOR MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMER ADVANTIM POST STAB LSI TIBIAL INSERT Implant KNEE COMPONENT-DEVICE 2 KRP WRIGHT MEDICAL TECHNOLOGY, INC. NA 104A004908

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention