BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTIONS STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 1031575 · Received April 18, 2008

    Report

    Report Number
    1822565-2008-00190
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    November 14, 2007
    Report Date
    March 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - IT IS REPORTED THAT THE RIGHT KNEE OF THE PT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE PT AGE, WEIGHT AND THE ACTIVITY LEVEL ARE NOT KNOWN. NO PARTS WERE RETURNED FOR EVALUATION. ALSO, THE PRE-OP X-RAYS ARE NOT AVAILABLE FOR REVIEW. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 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 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 ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2006. REVISION SURGERY OCCURRED DUE TO LOOSENING. EXACT DATE OF THE REVISION SURGERY IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTIONS STEMMED TIBIAL COMPONENT PRECOAT KNEE PROSTHESIS HSH ZIMMER, INC. NA 60358898

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R