BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESIDE ORTHOLOC II METAL BACK PATELLA

    MDR report key: 119021 · Received August 6, 1997

    Report

    Report Number
    1043534-1997-00104
    Event Type
    Injury
    Date Received
    August 6, 1997
    Date of Event
    December 10, 1996
    Report Date
    February 12, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: NO CONCLUSION CAN BE DRAWN. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. 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 HAD FAILED WHITESIDE LEFT KNEE PROSTHESIS REMAINED. RECORDS NOT AVAILABLE. ALLEGEDLY A BROKEN PARTICULAR COMPONENT FOUND IN OR ALONG WITH A BROKEN TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESIDE ORTHOLOC II METAL BACK PATELLA Implant KNEE COMPONENT - DEVICE 3 HTG WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other