BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREAT TOE SYSTEM

    MDR report key: 12922 · Received April 25, 1994

    Report

    Report Number
    MW1001716
    Event Type
    Injury
    Date Received
    April 25, 1994
    Report Date
    April 18, 1994
    Manufacturer
    ACUMED, INC.
    Product Code
    KWD
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD BILATERAL ARTHROPLASTY ON FIRST METATARSAL-PHALANGEAL JOINT IN 12/93. PT DEVELOPED PAIN AND EDEMA IN THE LEFT FOOT ONLY AND WAS TREATED WITH STEROID INJECTIONS, NSAIDS, IMMOBILIZATION, AND PHYSICAL THERAPY. THE PT ALSO HAD TWO WEEKS ON INTERFERENTIAL WAVE THERAPY. ON 4/15/94 THE LEFT FOOT IMPLANT WAS REMOVED. THE MARROW CAVITY OF BOTH THE PHALANX AND THE FIRST METATARSAL WERE PERMEATED WITH A BLACK SUBSTANCE, REMOVABLE WITH CURETTAGE AND LAVAGE. ALSO THE CAPSULE OF THE JOINT HAD THE SINUS CAVITY IMPREGNATED THROUGH AND THROUGH ON MEDIAL SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREAT TOE SYSTEM Implant IMPLANT TWO PART FOR HALLUX RIGIDUS KWD ACUMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention| S