BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMER ADVANTIM POST. STAB LSI TIBIAL INSERT

    MDR report key: 87073 · Received April 23, 1997

    Report

    Report Number
    1043534-1997-00046
    Event Type
    Injury
    Date Received
    April 23, 1997
    Date of Event
    March 18, 1997
    Report Date
    April 23, 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

    CONCLUSION STATEMENT: THERE WAS NO DEVICE FAILURE. PRODUCT LISTED ON MEDWATCH FROM USER FACILITY IS INCORRECT.

    Description of Event or Problem · 1

    LEFT SUPRA CONDYLAR FEMUR FRACTURE. LEFT TOTAL KNEE WITH LOOSENING OF TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMER ADVANTIM POST. STAB LSI TIBIAL INSERT Implant KNEE COMPONENT - DEVICE 1 KRP WRIGHT MEDICAL TECHNOLOGY, INC. NA 084A005292

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention