BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 1082797 · Received July 24, 2008

    Report

    Report Number
    1822565-2008-00440
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 14, 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: WEAR PERFORMANCE OF A COMPONENT IS DEPENDENT ON MANY FACTORS, INCLUDING PATIENT ACTIVITY AND PATIENT WEIGHT, MANY OF WHICH ARE OUT OF THE CONTROL OF THE MANUFACTURER. THE PROBABLE CAUSE OF THE FAILURE IS NORMAL WEAR AND TEAR. 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 INFORMATION 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 2003. FIVE YEARS POST-OP, PATIENT HAS A COMPLICATION OF 1MM ARTICULAR POLYETHYLENE EXCESSIVE WEAR ON THE OPERATIVE KNEE. PATIENT IS TOLERATING THE COMPLICATION, NO REVISION IS PLANNED.

    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 1540264

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR