BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC WRIST IMPLANT

    MDR report key: 21917 · Received April 21, 1995

    Report

    Report Number
    21917
    Event Type
    Injury
    Date Received
    April 21, 1995
    Date of Event
    April 12, 1995
    Report Date
    April 20, 1995
    Manufacturer
    UNKNOWN
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT IMPLANT PLACEMENT IN LEFT WRIST DURING 1988. SHE BEGAN TO COMPLAIN OF PAIN AND SWELLING APPROX 2 WEEKS PRIOR TO ADMISSION. THE PT WAS TAKEN TO SURGERY WHERE EROSION OF THE IMPLANT WAS FOUND. THE IMPLANT WAS REMOVED AND THE PT UNDERWENT LIGAMENT RECONSTRUCTION AND TENDON INTERPOSITION, AS WELL AS CARPOMETACARPAL EXCISIONAL ARTHROPLASTY. INITIAL SURGERY WAS PERFORMED AT ANOTHER FACILITY. IMPLANTED 1988. EXPLANTED 4/12/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC WRIST IMPLANT Implant SILASTIC WRIST IMPLANT KWM UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R