BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK

    MDR report key: 12127611 · Received July 7, 2021

    Report

    Report Number
    3010536692-2021-00354
    Event Type
    Injury
    Date Received
    July 7, 2021
    Report Date
    September 9, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 UNDERWENT L THR ON (B)(6) 2021. REVISED ON (B)(6) 2021 DUE TO INFECTION. WASHOUT PERFORMED, LINER AND HEAD REPLACED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023095 RIM-LOCK HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHA04612 1860617

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention