BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 1345348 · Received January 8, 2009

    Report

    Report Number
    1822565-2009-00014
    Event Type
    Malfunction
    Date Received
    January 8, 2009
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: NO PRODUCT HAS BEEN RETURNED SINCE REVISION SURGERY HAS NOT YET TAKEN PLACE. PARTS HAVE BEEN IMPLANTED FOR OVER 9.5 YRS. 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. THE INVESTIGATION WAS CONDUCTED IN THE FOLLOWING AREAS: LITERATURE SEARCH, CLINICAL DATA, HISTOLOGY ANALYSIS, DESIGN ASPECTS, WEAR TESTING, LOCKING MECHANISM TESTING, N-K II MICRO-MOTION TESTING, AND FEA OF N-K II BASEPLATE/SCREW INTERACTION. 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 DEVICE WAS IMPLANTED 1999. REVISION SURGERY IS PLANNED FOR AN UNK DATE DUE TO STAGE 2 OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT KNEE PROSTHESIS HSH ZIMMER, INC. NA 1364679

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK