BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 5467949 · Received February 29, 2016

    Report

    Report Number
    3007963827-2016-00011
    Event Type
    Injury
    Date Received
    February 29, 2016
    Report Date
    November 16, 2015
    Manufacturer
    ZIMMER, BUILDING #2
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). OTHER DEVICE USED: CATALOG #00597206535, NEXGEN ALL POLY PATELLA, LOT #UNKNOWN - MANUFACTURED BY ZIMMER B.V. - PONCE, P.R. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THESE DEVICES ARE USED FOR TREATMENT. PER THE PACKAGE INSERTS OF THE FEMORAL AND PATELLAR COMPONENTS, PAIN IS A KNOWN ADVERSE EFFECT OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE COMPLAINT WILL BE REVISED UPON RETURN OF X-RAYS AND/OR PRODUCT OR FURTHER INFORMATION. THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING RADIATING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123928 NEXGEN CR-FLEX GSF FEMORAL COMPONENT JWH JWH ZIMMER, BUILDING #2 62044002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other