BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK

    MDR report key: 12844089 · Received November 19, 2021

    Report

    Report Number
    3010536692-2021-00563
    Event Type
    Injury
    Date Received
    November 19, 2021
    Report Date
    November 19, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE. COMPONENTS NOT REVISED: PROFEMUR TL CLASSIC FIXED NECK SIZE 6 PRTLS026 1892400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741317 RIM-LOCK HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHA04658 1881599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown