BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL - KNEE II STEMMED TIBIAL BASEPLATE

    MDR report key: 3042083 · Received April 4, 2013

    Report

    Report Number
    1822565-2013-00604
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. 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. 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 ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138002 NATURAL - KNEE II STEMMED TIBIAL BASEPLATE JWH ZIMMER, INC. 1614377

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NATURAL-KNEE ULTRA CONGURENT TIBIAL INSERT| CATALOG #627501609, LOT #1615269