BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TRABECULAR METAL TIBIAL TRAY

    MDR report key: 2033449 · Received March 24, 2011

    Report

    Report Number
    1822565-2011-00738
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    April 1, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST OPERATION (PRIMARY SURGERY) X-RAYS ARE RETURNED FOR ANALYSIS AND SHOW RADIOLUCENT LINES UNDER THE TIBIAL COMPONENT, INDICATING LOOSENING OF THE TIBIAL COMPONENT. TIBIAL COMPONENT LOOSENING, IN GENERAL, CAN BE DUE TO MANY FACTORS INCLUDING, BUT NOT LIMITED TO, INSUFFICIENT BONE CONTACT WITH THE IMPLANT, SURGICAL TECHNIQUE, MICRO MOTION, PT ACTIVITY, OR PT WEIGHT. HOWEVER, WITH THE AVAILABLE INFORMATION, THE EXACT CAUSE FOR THE PT'S PAIN AND COMPONENT LOOSENING CANNOT BE DETERMINED. EVALUATION: 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS PAIN DUE TO POTENTIAL TIBIA PLATE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN TRABECULAR METAL TIBIAL TRAY MBH ZIMMER, INC. 61187135

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other