BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD

    MDR report key: 4241939 · Received November 10, 2014

    Report

    Report Number
    3010536692-2014-01594
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    August 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-01595. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO INFECTION (RIGHT). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723957 LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 1475084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention