BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC II POST STAB TIBIAL INSERT

    MDR report key: 130408 · Received October 31, 1997

    Report

    Report Number
    1043534-1997-00168
    Event Type
    Injury
    Date Received
    October 31, 1997
    Date of Event
    October 1, 1997
    Report Date
    October 2, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC. PRODUCT WAS NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    ALLEGEDLY TIBIAL STEM WAS BROKEN BELOW TIBIAL TRAY. THIS IS THE PT'S THIRD REVISON. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC II POST STAB TIBIAL INSERT Implant KNEE COMPONENT HSH WRIGHT MEDICAL TECHNOLOGY, INC. NA 01714487

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention