BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL COMPONENT

    MDR report key: 1576534 · Received January 12, 2010

    Report

    Report Number
    1822565-2010-00013
    Event Type
    Injury
    Date Received
    January 12, 2010
    Date of Event
    December 2, 2009
    Report Date
    December 4, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICES WERE IN-VIVO FOR 9+ YEARS. IMPLANTS WERE NOT RETURNED FOR EVAL. THERE IS INSUFFICIENT EVIDENCE AVAILABLE TO DETERMINE PROBABLE CAUSE OF THE COMPLAINT. 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2000 AND THAT THE PT WAS REVISED IN 2009 BECAUSE THE DEVICE WAS LOOSENING AND CAUSING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. NA 66351900

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R