BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT CERAMIC FEMORAL HEAD

    MDR report key: 116665 · Received August 29, 1997

    Report

    Report Number
    1043534-1997-00136
    Event Type
    Injury
    Date Received
    August 29, 1997
    Date of Event
    April 23, 1997
    Report Date
    May 27, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: THERE WAS NO DEVICE FAILURE. 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

    REVISION SURGERY WAS PERFORMED FOR AN ALLEGEDLY BROKEN STEM. THIS COMPONENT WAS REVISED AT THAT TIME. NO COMPLAINT WAS STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLT CERAMIC FEMORAL HEAD Implant HIP COMPONENT - DEVICE 3 LZO WRIGHT MEDICAL TECHNOLOGY, INC. NA 013M734660R

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention