BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS(R) FEMORAL HEAD

    MDR report key: 4121669 · Received September 26, 2014

    Report

    Report Number
    3010536692-2014-01428
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    March 11, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-01429, -01430, -01431.

    Description of Event or Problem · 1

    ALLEGEDLY AFTER 7 MTHS POST-OP, PT. STARTED HAVING BILATERAL/CHRONIC PAIN; DIFFICULTY WITH WALKING AND MOVEMENT. RECEIVED ADDITIONAL INFORMATION ON 9/02/14: PATIENT WAS REVISED ON (B)(6) 2014 (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601917 CONSERVE(R) TOTAL A-CLASS(R) FEMORAL HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 1426349

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention