BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RENAISSANCE(R) STEM

    MDR report key: 8408250 · Received March 11, 2019

    Report

    Report Number
    3010536692-2019-00520
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    September 1, 2018
    Report Date
    March 11, 2019
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT REPORTED INCREASING PAIN IN LLE STARTING IN (B)(6) 2018. MOD STEM FOUND TO BE LOOSE/BROKEN AT THE SPLINES IN THE FEMUR. NO TRAUMA NOTED. REMOVED THE STEM AND REPLACED WITH CLASSIC REN STEM AND NEW DELTA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203267 PROFEMUR(R) RENAISSANCE(R) STEM HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. PLS0-S412 1397256

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention