BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESIDE II TIBIAL IMPLANT

    MDR report key: 98531 · Received June 4, 1997

    Report

    Report Number
    1043534-1997-00064
    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
    HSH
    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: NO CONCLUSION CAN BE DRAWN. 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

    ALLEGEDLY REVISION SURGERY WAS PERFORMED DUE TO BROKEN IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESIDE II TIBIAL IMPLANT Implant KNEE COMPONENT-DEVICE 2 HSH WRIGHT MEDICAL TECHNOLOGY, INC. NA 14251

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention