BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC ADVANTIM LSI TIBIAL INSERT

    MDR report key: 302345 · Received October 27, 2000

    Report

    Report Number
    1043534-2000-00105
    Event Type
    Injury
    Date Received
    October 27, 2000
    Date of Event
    September 22, 2000
    Report Date
    September 29, 2000
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY PLASTIC WORN ON LATERAL SIDE AND BASE WORN ON LATERAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC ADVANTIM LSI TIBIAL INSERT KNEE COMPONENT KRP WRIGHT MEDICAL TECHNOLOGY, INC. NA 061M619320

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention