BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 2792311 · Received October 12, 2012

    Report

    Report Number
    2648920-2012-00219
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE TIBIAL COMPONENT LOOSENING. ALSO REPORTED IS THAT THERE WAS POSTERIOR SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 60698603

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention PALACOS R BONE CEMENT, CATALOG #UNK, LOT #UNK| THIS BONE CEMENT IS MANUFACTURED AT HERAEUS| SURGICAL PRODUCTS.| (B)(4) AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC