BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR PROLONG ARTICULAR SURFACE

    MDR report key: 2120037 · Received June 7, 2011

    Report

    Report Number
    1822565-2011-01325
    Event Type
    Injury
    Date Received
    June 7, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE STERILIZATION PROCESS FOR THIS DEVICE WAS VALIDATED IN ACCORDANCE WITH (B)(4) AND (B)(4) TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. IN ADDITION, BEFORE EACH MFG LOT IS RELEASED, THE "CERTIFICATE OF PROCESSING" FROM (B)(6) (STERILIZATION SUPPLIER) IS REVIEWED FOR CONFORMANCE. THIS CERTIFICATE LISTS THE MAXIMUM, MINIMUM, AND ACTUAL GAMMA DOSE IN (B)(6). THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE PT INFECTION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORD 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 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 HOSPITALIZED DUE TO INFECTION AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR PROLONG ARTICULAR SURFACE JWH ZIMMER INC. 60911118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN MIS TM TIBIAL TRAY: CATALOG # 00595403701,| NEXGEN CR FEMORAL COMPONENT: CATALOG #00596601502,| LOT #60900740| LOT #60932072, MFG ZIMMER (B)(4)| NEXGEN ALL POLY PATELLA: CATALOG # 00597206529,| LOT #60493847