BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK

    MDR report key: 11659743 · Received April 13, 2021

    Report

    Report Number
    3010536692-2021-00208
    Event Type
    Injury
    Date Received
    April 13, 2021
    Report Date
    June 10, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING COMPONENTS NOT REVISED: PROFEMUR XM STEM SIZE 0 / PRODUCT ID: PHA06000 / LOT NO.: 1659776. PROFEMUR® NECK NEUTRAL SHORT / PRODUCT ID: PHA01202 / LOT NO.: 1666220. PROFEMUR® XM DISTAL CENTRALIZER / PRODUCT ID: PRXMDC01 / LOT NO.: 15571341622616. MHRA REFERENCE NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559133 RIM-LOCK HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHA04658 1658748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention