BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNASTY® BIOFOAM SHELL

    MDR report key: 5974082 · Received September 23, 2016

    Report

    Report Number
    3010536692-2016-01177
    Event Type
    Other
    Date Received
    September 23, 2016
    Date of Event
    July 14, 2016
    Report Date
    September 26, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY THE PATIENT HAD HIP REPLACEMENT SURGERY ON (B)(6)2015. REVISED BIOLOX DELTA FEMORAL HEAD DUE TO UNKNOWN REASONS ON (B)(6)2015 AND REPLACED WITH LINEAGE TRANSCEND COCR FEMORAL HEAD. REVISED DYNASTY BIOFOAM SHELL AND POLY LINER DUE TO INSTABILITY IN (B)(6)2016. REPLACED WITH ANOTHER MANUFACTURERS ACETABULAR PRODUCT. DATE SPONSOR BECAME AWARE OF INCIDENT: 29 JULY 2016.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT HAD HIP REPLACEMENT SURGERY ON (B)(6) 2015. REVISED BIOLOX DELTA FEMORAL HEAD DUE TO UNKNOWN REASONS ON (B)(6) 2015 AND REPLACED WITH LINEAGE TRANSCEND COCR FEMORAL HEAD. REVISED DYNASTY BIOFOAM SHELL AND POLY LINER DUE TO INSTABILITY IN (B)(6) 2016. REPLACED WITH ANOTHER MANUFACTURERS ACETABULAR PRODUCT. DATE SPONSOR BECAME AWARE OF INCIDENT: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623922 DYNASTY® BIOFOAM SHELL DYNASTY(R) BF SHELL KWA MICROPORT ORTHOPEDICS INC. 15702411574202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention