BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTICEL

    MDR report key: 445387 · Received February 28, 2003

    Report

    Report Number
    445387
    Event Type
    Injury
    Date Received
    February 28, 2003
    Date of Event
    February 20, 2003
    Report Date
    February 26, 2003
    Manufacturer
    GENZYME TISSUE REPAIR
    Product Code
    NCO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 4-3-03: LETTER CONTAINS INFO CONCERNING AN ADVERSE EVENT EXPERIENCED AFTER IMPLANTATION OF CARTICEL (AUTOLOGOUS CULTURED CHONDROCYTES). GENZYMES BIOSURGERY MANUFACTURES CARTICEL UNDER A BIOLOGICS LICENSE APPLICATION AND ADVERSE EVENT REPORTS ARE SUBMITTED PER 21 CFR 600.80. THE INFO THEY RECEIVED REGARDING THE REFERENCED EVENT WAS SUBMITTED TO THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH ON MARCH 11, 2003 ON MEDWATCH FORM 3500A.

    Description of Event or Problem · 1

    PT HAD SURGERY FOR ANTEROMEDIALIZATION AND BIPOLAR PATELLOFEMORAL AUTOLOGOUS-CULTURED CHONDROCYTE IMPLANTATION DEEP MICROSUTURE PERIOSTEAL PATCHES. THE NEXT DAY DEVELOPED FEVER, PAIN, AND ELEVATED WHITE COUNT TO 27,000. DIAGNOSED AS SEPTIC JOINT IN OPERATIVE KNEE. OPEN DEBRIDEMENT AND REMOVAL OF THE CARTICEL CELLS IMPLANT ONE DAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTICEL CARTILAGE IMPLANT NCO GENZYME TISSUE REPAIR NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention