BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2133535 · Received June 15, 2011

    Report

    Report Number
    1822565-2011-01419
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    October 29, 2010
    Report Date
    May 19, 2011
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE LEFT KNEE ASPIRATION WAS MOST LIKELY DUE TO TIBIAL LOOSENING TO ANALYZE THE JOINT FLUID AS WELL AS ALLEVIATE JOINT PAIN. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. THE SURGICAL NOTES FROM WHEN THE DEVICES WERE IMPLANTED WERE REVIEWED AND DID NOT INDICATE ANY COMPLICATIONS. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE MOST LIKELY ROOT CAUSE OF THE ASPIRATION IS TIBIAL LOOSENING. 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 RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT LEFT KNEE ASPIRATION DUE TO PAIN AND POSSIBLE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER INC. 60854135

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention