BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PLYETHYLENE LPS-FLEX ART SURFACE

    MDR report key: 1833738 · Received September 8, 2010

    Report

    Report Number
    1822565-2010-00661
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE STERILIZATION PROCESS FOR THIS DEVICE WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE RIGHT KNEE. THE SURGEON REMOVED THE ARTICULAR SURFACE AND WASHED THE JOINT WITH ANTIBIOTIC SOLUTION THEN REPLACED IT WITH A NEW ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PLYETHYLENE LPS-FLEX ART SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 61460506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention