BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) PC HA QUAD HEMI FLARE STANDARD SHELL

    MDR report key: 3802427 · Received May 9, 2014

    Report

    Report Number
    3010536692-2014-00771
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    January 14, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN THE (B)(6). THIS IS THE SAME EVENT AS 3010536692-2014-00772, 00773, 00774.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN (LEFT). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281965 LINEAGE(R) PC HA QUAD HEMI FLARE STANDARD SHELL HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 075230127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention