BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL BCH FEMORAL HEAD

    MDR report key: 6202131 · Received December 23, 2016

    Report

    Report Number
    3010536692-2016-01552
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY, HEAD WORE THROUGH POLY AND INTO DYNASTY SHELL. THE SHELL WAS COMPROMISED SO THE SURGEON FELT IT BEST TO REMOVE AND REPLACE WITH A BIOMET CUP. X-RAYS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852470 CONSERVE(R) TOTAL BCH FEMORAL HEAD HIP IMPLANT LZO MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention