BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK

    MDR report key: 8023721 · Received October 31, 2018

    Report

    Report Number
    3010536692-2018-01392
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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

    PER ARTICLE BY ZAJC, ET AL., EJOST. 2018 DEC. ALLEGEDLY, IN 2015, A (B)(6) MALE UNDERWENT A REVISION FOR PAIN AND INSTABILITY OF THE RIGHT HIP. RADIOGRAPHS REVEALED DECENTRALIZATION OF THE FEMORAL HEAD, AND THE PATIENT WAS REVISED. AT REVISION, THE POLYETHYLENE LINER WAS FOUND BROKEN AND THE ACETABULAR SHELL DAMAGED IN RETROVERSION. IT WAS IMPOSSIBLE TO DISENGAGE THE MODULAR NECK FORM THE TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864969 RIM-LOCK HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHA0-46XX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention