BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN OPS-FLEX ARTICULAR SURFACE

    MDR report key: 1980182 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00155
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 12, 2011
    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

    EVAL SUMMARY: PRODUCT WAS NOT RETURNED FOR EVAL. 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 MFG LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. IN ADDITION, BEFORE EACH MFG LOT IS RELEASED, THE "CERTIFICATE OF PROCESSING" FROM THE STERILIZATION SUPPLIER IS REVIEWED FOR CONFORMANCE. THIS CERTIFICATE LISTS THE MAXIMUM, MINIMUM AND ACTUAL GAMMA DOSE IN KGY. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN OPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61415735

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention