BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTIC

    MDR report key: 1051884 · Received May 21, 2008

    Report

    Report Number
    1822565-2008-00253
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: 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. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT KNEE REPLACEMENT IN 2006, AND WAS REVISED IN 2008, DUE TO PERSISTENT PAIN AND A CLICKING NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTIC KNEE PROSTHESIS JWH ZIMMER, INC. NA 78881200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R