BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 8853670 · Received August 1, 2019

    Report

    Report Number
    3010536692-2019-00965
    Event Type
    Injury
    Date Received
    August 1, 2019
    Report Date
    August 1, 2019
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SEE ATTACHED. - ATTACHMENT: [RIPOJULY2019SIGNED.PDF].

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 64 PPR67264 LOT S05105225. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 16D PPR67624 LOT T01119404. INSERT CERAM "ANCA FIT?" 28/48 60-62-64-66/28 AL2.O3 B. FORTE PPR67514 LOT S07115059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647631 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01244 T02121639X1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention