BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC II TOTAL CONDYLAR TIBIAL INSERT

    MDR report key: 113780 · Received August 14, 1997

    Report

    Report Number
    1043534-1997-00128
    Event Type
    Injury
    Date Received
    August 14, 1997
    Date of Event
    June 10, 1997
    Report Date
    July 16, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: NO CONCLUSION CAN BE DRAWN. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CONRNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY,INC.

    Description of Event or Problem · 1

    ALLEGEDLY PT HAS FRACTURE OF INTERNAL UPPER PART OF FEMUR CONDYLIS IN PROSTHESIS.

    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 M358350

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R