BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 3031991 · Received March 28, 2013

    Report

    Report Number
    1822565-2013-00555
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-04/19/2010-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD ACTION WAS CONDUCTED ON (B)(4), 2010 PER RECALL NUMBER 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 HOWEVER, IT IS UNKNOWN IF A DROP DOWN STEM WAS USED. IF A DROP DOWN STEM WAS NOT USED, IT IS LIKELY THAT THE LACK OF A DROP DOWN STEM CONTRIBUTED TO THE TIBIAL LOOSENING. WITH THE INFORMATION PROVIDED, A CAUSE CANNOT BE DETERMINED FOR THE REPORTED FEMORAL COMPONENT 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL AND FEMORAL COMPONENT WITH SEVERE FUNCTIONAL LIMITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127553 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 60682184

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention CATALOG #00596401752, LOT #60909520| NEXGEN LPS-FLEX FEMORAL COMPONENT