BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NK II CONGRUENT TIBIAL INSERT

    MDR report key: 2113536 · Received June 1, 2011

    Report

    Report Number
    1822565-2011-01299
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    March 23, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: CLINICAL STUDIES HAVE SHOWN THAT THE DEVELOPMENT OF OSTEOLYTIC LESIONS IS FREQUENTLY ASSOCIATED WITH GENERATION OF WEAR DEBRIS. IN THE PAST, THE OCCURRENCE OF THESE LESIONS IN N-K II CONVENTIONAL POLYETHYLENE (SULENE) HAS BEEN EXTENSIVELY INVESTIGATED; HOWEVER, NO ROOT CAUSE WAS ABLE TO BE IDENTIFIED. 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 RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S KNEE WAS REVISED FOR OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NK II CONGRUENT TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER, INC. 1538923

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG #621200210, LOT #1552951| NK II POROUS COATED STEMMED TIBIAL BASEPLATE: