BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC ADVANTIM TOT COND TIBIAL INSERT

    MDR report key: 134934 · Received November 25, 1997

    Report

    Report Number
    1043534-1997-00186
    Event Type
    Injury
    Date Received
    November 25, 1997
    Date of Event
    October 20, 1997
    Report Date
    October 30, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: USER ERROR CONTRIBUTED TO THE EVENT. PRODUCT WAS MFG AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED KNEE SURGERY WAS PERFORMED DUE TO PATIENT PAIN. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC ADVANTIM TOT COND TIBIAL INSERT Implant KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA 010M391570

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention