BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2275412 · Received September 29, 2011

    Report

    Report Number
    1822565-2011-02170
    Event Type
    Injury
    Date Received
    September 29, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-04/19/2010-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE TIBIAL COMPONENT WAS DISCARDED AND IS UNAVAILABLE FOR RETURN. NO X-RAYS OR OPERATIVE NOTES WERE PROVIDED. THE DEVICES WERE IN VIVO APPROXIMATELY TWO YEARS AND TEN MONTHS. A FIELD ACTION WAS CONDUCTED ON APRIL 19, 2010 PER RECALL UMBER 1822565-04/19/2010-001, IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S TIBIAL COMPONENT BECAME LOOSE ASEPTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 61029267

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention