BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC II TOTAL CONDYLAR TIBIAL INSERT

    MDR report key: 41330 · Received October 4, 1996

    Report

    Report Number
    1043534-1996-00025
    Event Type
    Injury
    Date Received
    October 4, 1996
    Date of Event
    August 7, 1996
    Report Date
    October 4, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS MFG AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC. CONCLUSION STATEMENT: PRODUCT WORN DUE TO FRACTURED FEMORAL COMPONENT.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO BROKEN FEMORAL COMPONENT AND BROKEN TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC II TOTAL CONDYLAR TIBIAL INSERT Implant KNEE COMPONENT - DEVICE 2 JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention