BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MEDICAL PIVOT KNEE

    MDR report key: 1157438 · Received September 11, 2008

    Report

    Report Number
    1043534-2008-00239
    Event Type
    Injury
    Date Received
    September 11, 2008
    Report Date
    August 20, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED. EVENT DEVICE CODES ADDRESSED IN PACKAGE INSERTS. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THESE EVENTS OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    IN THE MAY 9, 2008, E-PUBLISHED ARTICLE OF CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, DR YOUNG-HOO KIM, DR SUNG-HWAN YOON, AND DR. JUN-SHIK KIM REPORTED THE "EARLY OUTCOME OF TKA WITH A MEDIAL PIVOT FIXED-BEARING PROSTHESIS IS WORSE THAN WITH A PFC MOBILE-BEARING PROSTHESIS", WHERE PTS WERE IMPLANTED WITH A MEDIAL PIVOT PROSTHESIS IMPLANTED IN THE ONE KNEE AND A PFC SIGMA PROSTHESIS IMPLANTED IN 2004. ALLEGEDLY, FIVES PTS HAD INFECTIONS, ONE PT HAD SUFFERED RANGE OF MOTION, AND SOME PTS REPORTED TO HAVE REACTIONS TO PROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MEDICAL PIVOT KNEE NONE JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R