BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR TRANSCEND® FEMORAL HEAD

    MDR report key: 7969936 · Received October 16, 2018

    Report

    Report Number
    3010536692-2018-01303
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    PMA / PMN Number
    K004043
    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
    809563 COCR TRANSCEND® FEMORAL HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 2600-0026 1694044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention