BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT PRECOAT

    MDR report key: 1021936 · Received March 28, 2008

    Report

    Report Number
    1822565-2008-00136
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PREVIOUSLY ADDRESSED SUPPLIER ISSUE. EVALUATION: THE PRODUCT STATED IN THE COMPLAINT WAS NOT RETURNED FOR REVIEW. HOWEVER, 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 A 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 HAVE 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 AWARE OF THIS POTENTIAL ISSUE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY IN 2008, THE PLASTIC BAG CONTAINING THE IMPLANT WAS FOUND TO BE STUCK TO THE IMPLANT. ANOTHER DEVICE WAS NOT AVAILABLE SO THE IMPLANT WAS CLEANED AND IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT PRECOAT KNEE PROSTHESIS HSA ZIMMER, INC. NA 60358110

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR