BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON FINGER JOINT IMPLANT

    MDR report key: 284993 · Received July 6, 2000

    Report

    Report Number
    MW1019252
    Event Type
    Injury
    Date Received
    July 6, 2000
    Date of Event
    February 23, 1996
    Report Date
    May 8, 2000
    Manufacturer
    DOW CORNING CORP.
    Product Code
    KWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    1996 INSERTION OF SWANSON SILASTIC MCP REPLACEMENTS IN PT. 1/2000 INCREASING PAIN AND SWELLING. IN 2000 PROSTHESIS REMOVED. FRAGMENTATION OF SILASTIC AND METAL GROMMET NOTED. METALLOSIS OF TISSUES. NEW JOINTS NOT REINSERTED. JOINTS X2 LEFT AS PSEUDOARTHROSIS. NO SIGN OR EVIDENCE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWANSON FINGER JOINT IMPLANT SWANSON FINGER JOINT IMPLANT KWF DOW CORNING CORP. SILASTIC HP 100 NA
    2 SWANSON FINGER JOINT IMPLANT SWANSON FINGER JOINT IMPLANT KWF DOW CORNING CORP. SILASTIC HP 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention