BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE-NAME UNKNOWN

    MDR report key: 46508 · Received October 29, 1996

    Report

    Report Number
    1043534-1996-00032
    Event Type
    Injury
    Date Received
    October 29, 1996
    Date of Event
    September 9, 1994
    Report Date
    October 29, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNONLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: NO CONCLUSION CAN BE DRAWN. THE USER REFUSED TO PROVIDE SUFFICIENT INFO FOR EVAL. PRODUCT WAS MFR AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Description of Event or Problem · 1

    ALLEGEDLY KNEE COMPONENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL KNEE-NAME UNKNOWN Implant KNEE COMPONENTS JWH WRIGHT MEDICAL TECHNONLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention