BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD

    MDR report key: 3790236 · Received May 5, 2014

    Report

    Report Number
    3010536692-2014-00735
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 4, 2006
    Report Date
    May 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    PMA / PMN Number
    P030027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 3010536692-2014-00734.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266238 LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD HIP COMPONENT MRA MICROPORT ORTHOPEDICS INC. 084104107

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention