BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N-K II ULTRA CONGRUENT TIBIAL INSERT

    MDR report key: 3812563 · Received May 2, 2014

    Report

    Report Number
    1822565-2014-00555
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. 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 SUGGEST 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. REF. MDR 1822565-2006-00284 FOR ADD'L INFO REGARDING THE CORRECTIVE ACTION TAKEN. EVALUATION: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND IT APPEARS THAT THE LOTS IN QUESTION WERE PRODUCED, INSPECTED, AND PACKAGED WITHIN ESTABLISHED AND VALIDATED PROCESS PARAMETERS. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265313 N-K II ULTRA CONGRUENT TIBIAL INSERT JWH ZIMMER, INC. 60390201

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention NATURAL-KNEE II POROUS COATED STEMMED TIBIAL| BASEPLATE, CATALOG#621200210, LOT#60383385