BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II CONGRUENT TIBIAL INSERT

    MDR report key: 1901437 · Received November 11, 2010

    Report

    Report Number
    1822565-2010-01110
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BOTH ITEMS WERE RETURNED HEAVILY WORN AND GOUGED. NO X-RAYS WERE RETURNED FOR ANALYSIS. THE ARTICULAR SURFACE EXHIBITS BURNISHING AND WEAR ON THE PROXIMAL SURFACE CONSISTENT WITH 10 YEARS IN-VIVO. THERE ARE GROOVE MARKS ON THE SPINE PORTION OF THE ARTICULAR SURFACE, LIKELY DUE TO HYPEREXTENSION. THE BACKSIDE OF THE ARTICULAR SURFACE EXHIBITS COLD FLOW INTO THE SCREW HOLES AND ROTATIONAL WEAR MARKS. THE PATELLA, AS RETURNED, HAS BEEN SEPARATED FROM THE METAL BACK AND HAS A FRACTURE ALONG ONE EDGE WITH SOME SMALL CHIPS MISSING. IT IS UNKNOWN WHETHER OR NOT THE PRESENCE OF THE CYST IS DUE TO THE REPORTED POLYETHYLENE WEAR. IN GENERAL, POLYETHYLENE WEAR CAN BE ATTRIBUTED TO, BUT NOT LIMITED TO, PATIENT ANATOMY, IMPLANT PLACEMENT AND ALIGNMENT, THIRD BODY WEAR, OR TRAUMA TO THE JOINT. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION ACTION FOR IN 2007. THIS CORRECTIVE ACTION INVOLVED ENHANCING THE LABELING FOR THE NATURAL KNEE II KNEE SYSTEM. REFERENCE MDR 1822565-2006-00284 FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR POLY WEAR. A LARGE TIBIAL CYST WAS FOUND IN PROXIMAL TIBIA. THE DEVICE WAS IMPLANTED IN 2000.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention NATURAL KNEE II SYSTEM METAL BACKED PATELLA| COMPONENT: CATALOG #620001100, LOT #UNK