BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK

    MDR report key: 10337609 · Received July 29, 2020

    Report

    Report Number
    3010536692-2020-00504
    Event Type
    Injury
    Date Received
    July 29, 2020
    Report Date
    July 29, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN. REVISION NJR NUMBER: 4489044. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: PROFEMUR® L HIP STEM SIZE 3 HA COATED PRODUCT ID: PHA05506, LOT ID: 511348822. PROFEMUR® NECK 8DG A/R SHORT PRODUCT ID: PHA01232, LOT ID: 511357101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805138 RIM-LOCK HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHA04606 301078462

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention