BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE II CONGRUENT TIBIAL INSERT

    MDR report key: 1963596 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01426
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THERE ARE NO RETURNED PRODUCTS OR X-RAYS AVAILABLE TO STUDY THE IMPLANTATION TECHNIQUE. NEITHER OP-NOTES NOR RELEVANT PT DATA IS AVAILABLE AT THIS TIME. 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 CORRECTIVE ACTION 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. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    OSTEOLYSIS IS REPORTED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II CONGRUENT TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER, INC. 1402926

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR