BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 1321403 · Received February 20, 2009

    Report

    Report Number
    1822565-2009-00176
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    November 26, 2008
    Report Date
    January 21, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS PART OF THE COMPLAINT INVESTIGATION, A TEAM WAS FORMED TO INVESTIGATE A POSSIBLE CAUSE. THE TEAM EXPLORED 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. AFTER REVIEWING THESE ACTIVITIES, THE TEAM CONCLUDED THAT THERE IS NO DEFINITIVE CAUSE THAT EXPLAINS THE REPORTED OSTEOLYSIS. 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 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 IN 2003, AND THAT THE PT WAS REVISED IN 2008, DUE TO 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 1520458

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R