BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMER BRAND ADVANTIM LSI TIBIAL INSERT

    MDR report key: 219354 · Received April 14, 1999

    Report

    Report Number
    1043534-1999-00034
    Event Type
    Injury
    Date Received
    April 14, 1999
    Date of Event
    January 26, 1999
    Report Date
    March 18, 1999
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORIGINAL SURGERY: 3/19/98. ALLEGEDLY PATIENT HAD MEDIAL BONE LOSS UNDER TIBIAL PLATEAU. TIBIA COLLAPSED. CUSTOM IMPLANT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMER BRAND ADVANTIM LSI TIBIAL INSERT Implant KNEE COMPONENT KRP WRIGHT MEDICAL TECHNOLOGY, INC. NA 087A069336

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention