BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 1031169 · Received April 16, 2008

    Report

    Report Number
    1822565-2008-00184
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 18, 2008
    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: CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2005, AND 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 IMPLANT HSH ZIMMER, INC. NA 1582456

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R