BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC ADVANTIM TOT COND TIBIAL INSERT

    MDR report key: 174418 · Received June 26, 1998

    Report

    Report Number
    1043534-1998-00048
    Event Type
    Injury
    Date Received
    June 26, 1998
    Date of Event
    May 1, 1998
    Report Date
    May 29, 1998
    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: UNABLE TO DETERMINE CAUSE OF EVENT. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Description of Event or Problem · 1

    PT WAS REVISED BECAUSE ALLEGEDLY PT RUPTURED PCL AND HAD AN UNSTABLE PAINFUL KNEE. WORN POLY FOUND.

    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 M802190

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention