BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT

    MDR report key: 1061103 · Received June 13, 2008

    Report

    Report Number
    1822565-2008-00322
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PREVIOUSLY ADDRESSED SUPPLIER ISSUE. EVAL: THIS FEMORAL COMPONENT WAS PACKAGED WITH A RAW MATERIAL LOT OF POLYETHYLENE BAGS THAT WAS PREVIOUSLY IDENTIFIED AS HAVING THE POTENTIAL TO ADHERE TO HIGHLY POLISHED SURFACES, WHICH MAY LEAVE A RESIDUE AND IN SOME CASE PORTION OF POLYETHYLENE ON THE DEVICE. INDEPENDENT LAB TESTING FOUND THE RESIDUE TO BE NON-TOXIC. THIS CONDITION WAS CAUSED BY A VARIABILITY IN THE CHEMICAL CONSTITUENTS IN THE POLYETHYLENE FILM DURING THE EXTRUSION PROCESS. THE ZIMMER SPECIFICATION FOR POLYETHYLENE BAGS HAS BEEN REVISED TO ENSURE APPROPRIATE COMPOSITION LEVELS. ALL PRODUCT IN ZIMMER INVENTORY THAT WAS PACKAGED WITH THE SUSPECT RAW MATERIAL LOT WAS REWORKED AND A FIELD COMMUNICATION WAS RELEASED TO HEIGHTEN THE AWARENESS OF THIS POTENTIAL ISSUE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE HAD STUCK TO THE FIRST LAYER OF PACKAGING LEAVING A RESIDUE ON THE COMPONENT. SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. NA 60318481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK