BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II CONGRUENT TIBIAL INSERT

    MDR report key: 1892218 · Received October 26, 2010

    Report

    Report Number
    1822565-2010-00996
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    January 15, 2008
    Report Date
    September 29, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO 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 ADD'L INFO REGARDING THE CORRECTIVE ACTION TAKEN. 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. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL PLATE AND OSTEOLYSIS WHICH ALSO CAUSED DESTRUCTION OF THE TIBIAL BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II CONGRUENT TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER, INC. 1386438

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CATALOG# 621201220, LOT #1385384| NATURAL KNEE II POROUS COATED STEMMED TIBIAL| BASEPLATE