BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESIDE ORTHOLOC II FEMORAL PROSTHESIS

    MDR report key: 96944 · Received June 4, 1997

    Report

    Report Number
    1043534-1997-00063
    Event Type
    Injury
    Date Received
    June 4, 1997
    Date of Event
    February 19, 1997
    Report Date
    June 3, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGTH, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Description of Event or Problem · 1

    ALLEGEDLY REVISION SURGERY WAS PERFORMED DUE TO BROKEN IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESIDE ORTHOLOC II FEMORAL PROSTHESIS Implant KNEE COMPONENT - DEVICE 1 KWY WRIGHT MEDICAL TECHNOLOGY, INC. NA 12790

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention
    2