BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB

    MDR report key: 2066603 · Received April 20, 2011

    Report

    Report Number
    2066603
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 19, 2011
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT TRIATHLON TOTAL KNEE ARTHROPLASTY WITH TOBRAMYCIN-IMPREGNATED METHYL METHACRYLATE WITH #4 RIGHT FEMUR, #4 PRIMARY TIBIA, WITH 16-MM CSX-3 INSERT AND 35-MM ASYMMETRIC PATELLA WITH A NAVIGATION SYSTEM; SKIN WAS CLOSED WITH ABSORBABLE STAPLES. PATIENT WAS READMITTED WITH INFECTED HEMATOMA OF THE KNEE, UNDERWENT AN EXCISION OF NONVIABLE TISSUE, REMOVAL OF MULTIPLE FOREIGN BODIES, EVACUATION OF THE HEMATOMA, AND SPLIT THICKNESS SKIN GRAFT. THE FOREIGN BODIES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB STAPLER, SKIN, ABSORBABLE GDW INCISIVE SURGICAL, INC. 2030 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R| S