BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY® BF SHELL 60MM GROUP G

    MDR report key: 7969928 · Received October 16, 2018

    Report

    Report Number
    3010536692-2018-01301
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT HAD HIP REPLACEMENT SURGERY ON (B)(6) 2017. PATIENT HAD REVISION SURGERY ON (B)(6) 2018 DUE TO LEG LENGTH ISSUES. REVISED ACETABULAR SHELL AND LINER FROM GROUP G TO GROUP D. REVISED FEMORAL HEAD FROM NECK LENGTH 0 TO -3.5 SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809304 DYNASTY® BF SHELL 60MM GROUP G HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. DSBF-GG60 1570415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention