BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2100544 · Received May 17, 2011

    Report

    Report Number
    3007963827-2011-00001
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE INITIAL MEDWATCH REPORT 1822565-2011-00764, WHICH WAS SUBMITTED UNDER THE CORRECT REGISTRATION NUMBER. RECORDS INDICATE THE DEVICE WAS CLEARLY AND LEGIBLY LABELED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CR FLEX FEMUR WAS MISTAKENLY USED WITH A LPS ARTICULATING SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER 61716749

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other