BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY PRESS-FIT DISTAL STEM MICRO TAPER

    MDR report key: 93176 · Received May 22, 1997

    Report

    Report Number
    1043534-1997-00062
    Event Type
    Injury
    Date Received
    May 22, 1997
    Date of Event
    April 23, 1997
    Report Date
    May 21, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDI
    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: DEVICE FAILURE OCCURRED AND WAS RELATED TO THE EVENT. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, WHO ASSETS WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Description of Event or Problem · 1

    X-RAYS ALLEGEDLY INDICATE TAPER IS BROKEN. REVISION SURGERY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY PRESS-FIT DISTAL STEM MICRO TAPER Implant HIP COMPONENT JDI WRIGHT MEDICAL TECHNOLOGY, INC. NA 121M687810

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention