BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 2060867 · Received April 18, 2011

    Report

    Report Number
    9613369-2011-00019
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    April 15, 2011
    Manufacturer
    AARAU SWITZERLAND MANUFACTURING SITE
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION WAS REPORTED DUE TO AN INTRAOPERATIVE FEMORAL FRACTURE OCCURED DURING A R3 STUDY. THE FRACTURE HAS BEEN NOTICED 2 OR 3 DAYS AFTER THE SURGERY ON THE POSTOPERATIVE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS FEMORAL COMPONENT JDH AARAU SWITZERLAND MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R