BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEM NONAUGUMENTABLE TIBIAL COMPONENT

    MDR report key: 1901436 · Received November 11, 2010

    Report

    Report Number
    2648920-2010-00060
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CEMENTED IMPLANT WAS REMOVED AFTER BEING IMPLANTED FOR APPROXIMATELY FOUR YEARS AND THREE MONTHS. X-RAYS WERE NOT PROVIDED. WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE OF THE TIBIAL PLATE LOOSENING CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEM NONAUGUMENTABLE TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER 60471353

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention