BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 4796539 · Received May 26, 2015

    Report

    Report Number
    3010536692-2015-01097
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    May 2, 2013
    Report Date
    April 28, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 05/14/2015. THIS IS THE SAME EVENT AS 3010536692-2015-01075-01,-01076-01, 01098.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (LEFT). ADD'L INFO RECEIVED 05/14/2015: PAIN, AMBULATORY DIFFICULTY (TRENDELENBURG GAIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340712 CONSERVE(R) TOTAL A-CLASS HEAD CONSERVE BFH AM HEAD JDL MICROPORT ORTHOPEDICS INC. 1096370942

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention