BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC H.P.100 SWANSON WRIST JOINT IMPLANT WITH GROMMETS

    MDR report key: 89637 · Received May 6, 1997

    Report

    Report Number
    1816403-1997-00511
    Event Type
    Injury
    Date Received
    May 6, 1997
    Report Date
    March 7, 1997
    Manufacturer
    DOW CORNING CORP.
    Product Code
    KWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL STEM, MORE THAN 1/2 OF THE HINGE MIDSECTION AND THE DISTAL GROMMET WERE MISSING. SCRATCHES PROBABLY FROM INSTRUMENTS USED DURING THE EXPLANTATION SURGERY; WHITISH, FLAKY MATERIAL, BELIEVED TO BE SILICONE DEBRIS THAT WORE FROM THE IMPLANT; NOT POSSIBLE TO UNEQUIVOCALLY DETERMINE THE CAUSE OF THE COMPLICATIONS, HOWEVER, THE MORPHOLOGY OF THE IMPLANT SPECIMENS INDICATE THAT IMPLANT DESTRUCTION WAS CAUSED BY SEVERE CONDITIONS OF EXPOSURE WHILE IMPLANTED.

    Description of Event or Problem · 1

    REPORTER ALLEGES PATIENT'S IMPLANT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC H.P.100 SWANSON WRIST JOINT IMPLANT WITH GROMMETS Implant WRIST JOINT IMPLANT KWM DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention