BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION MCP

    MDR report key: 478357 · Received August 15, 2003

    Report

    Report Number
    1651501-2003-00022
    Event Type
    Other
    Date Received
    August 15, 2003
    Date of Event
    July 15, 2003
    Report Date
    August 13, 2003
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REQUESTED RAY AMPUTATION DUE TO PERSISTENT PAIN AND STIFFNESS FOLLOWING AN EXTENSIVE HISTORY OF TREATMENT FOR AN APRIL 2001 TRAUMA THAT INCLUDED: AN EXTENSIVE POST-TRAUMA INFECTION (STREP CELLULITIS) THAT REQUIRED 2 SURGICAL DEBRIDEMENTS; 2 IMMOBILIZATION ATTEMPTS MADE IN JULY 2001 AND JANUARY 2002; AND AN MCP TOTAL JOINT IMPLANT THAT WAS IMPLANTED IN 2002 AND THEN REPLACED IN 2003 WITH A 2ND MCP TOTAL JOINT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION MCP TOTAL FINGER JOINT IMPLANT KWF ASCENSION ORTHOPEDICS, INC. MCP-100 A32501D

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other