BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON GREAT TOE IMPLANT

    MDR report key: 490309 · Received October 10, 2003

    Report

    Report Number
    MW1029774
    Event Type
    Injury
    Date Received
    October 10, 2003
    Date of Event
    May 24, 2002
    Report Date
    October 10, 2003
    Manufacturer
    WRIGHT MEDICAL CORP
    Product Code
    KWD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SWANSON DOUBLE STEMMED GREAT TOE IMPLANT WAS USED IN AN IMPLANT ARTHROPLASTY PROCEDURE - CPT: 28293-ON THIS PT'S RIGHT 1ST MPJ. PT HAD AN IMMEDIATE UNEVENTFUL POST-OP COURSE. THREE MONTHS LATER, THE PT EXPERIENCED SEVERE PAIN IN THE AREA. TREATMENT CONTINUED FOR 6 MONTHS WITHOUT IMPROVEMENT. IN 2003 A SOFT TISSUE MASS WAS EXCISED FROM THE DORSUM OF THE THE RIGHT 1ST MPJ. FOLLOW UP X-RAYS SHOWED COMPRESSION OF IMPLANT AND DECREASE OF THE JOINT SPACE FROM PREVIOUS POST-OP X-RAYS. IMPLANT WAS SURGICALLY REMOVED IN 2003. THE IMPLANT HAD A BROKEN HINGE. IT WAS BROKEN INTO TWO PIECES. THE IMPLANT FAILED IN LESS THAN ONE YEAR FROM THE TIME OF THE INITIAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWANSON GREAT TOE IMPLANT IMPLANT FOR THE 1ST MPJ KWD WRIGHT MEDICAL CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention| S