BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE LUNATE IMPLANT

    MDR report key: 14127 · Received April 11, 1994

    Report

    Report Number
    14127
    Event Type
    Other
    Date Received
    April 11, 1994
    Date of Event
    February 7, 1994
    Report Date
    April 4, 1994
    Manufacturer
    UNKNOWN
    Product Code
    KWN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT DEMONSTRATED ALMOST COMPLETE VOLAR SUBLUXATION OF THE LUNATE IMPLANT ON PREOPERATIVE TOMOGRAPHY, IMPINGEMENT OF THE SCAPHOID IN THE SCAPHOID FOSSA, AND PROXIMAL MIGRATION OF THE CARPAL CAPITATE. AT SURGERY, IMPLANT WAS INTACT, BUT HAD AN EGG-YELLOW COLOR AND WAS MUCH SOFTER THAN NORMAL. FINDINGS CONSISTENT WITH POSSIBLE SILICONE SYNOVITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE LUNATE IMPLANT Implant SILICONE LUNATE IMPLANT KWN UNKNOWN NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other