BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2447531 · Received February 9, 2012

    Report

    Report Number
    1822565-2012-00215
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 12, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-4/19/2010-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: VISUAL ANALYSIS SHOWS THAT MOST OF THE PMMA COATING HAS BEEN REMOVED, INDICATING THAT IT BONDED WITH THE CEMENT. A FIELD ACTION WAS CONDUCTED ON (B)(6), 2010 PER RECALL NUMBER 1822565-04/19/2010-001-C, IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE. IT ALSO RECOMMENDED TO FULL CEMENT AND PRESSURIZE THE ANTERIOR AND POSTERIOR SURFACES OF THE TIBIAL COMPONENT AND TO CAREFULLY USE BONE CEMENT APPLICATION PER THE MFR'S INSTRUCTIONS. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION (NOTIFICATIONS WERE SENT ON (B)(6) 2010). IT IS LIKELY THAT THE LACK OF A DROP DOWN STEM AND THE CEMENT TECHNIQUE CONTRIBUTED TO LOOSENING. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: DIMENSIONAL ANALYSIS REVEALS THAT THE DEVICE IS WITHIN SPECS PER THE DEVICE PRINTS. THE MFG RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPEC.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 61097031

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention