BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II ALL POLY PATELLA

    MDR report key: 1999581 · Received February 16, 2011

    Report

    Report Number
    1822565-2011-00262
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PARTS WERE RETURNED FOR EVALUATION. HOWEVER, A PHOTO AND AN X-RAY IMAGE OF THE PATELLA WERE PROVIDED AND BOTH APPEAR TO CONFIRM THAT THE PATELLA HAD FRACTURED. NO IMAGES SHOWING THE ARTICULAR SURFACE WERE RETURNED. A COPY OF THE OPERATIVE PROCEDURE NOTE FROM THE PRIMARY SURGERY WAS PROVIDED. NOTHING IN THE REPORT SUGGESTED ANY SIGNIFICANT ISSUES FROM THE SURGERY. WITHOUT REVIEWING THE PRODUCTS OR RECEIVING ADDITIONAL INFO, AN EXACT CAUSE FOR THE PATELLA FRACTURE AND ARTICULAR SURFACE WEAR CANNOT BE DETERMINED. EVALUATION: 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 PT WAS REVISED FOR A BROKEN PATELLA AND WEAR ON THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II ALL POLY PATELLA KNEE PROSTHESIS JWH ZIMMER, INC. 61363279

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention NATURAL-KNEE II SYSTEM DURASUL ULTRACONGRUENT| TIBIAL INSERT, CATALOG #627602616, LOT #60631202