BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK

    MDR report key: 11657850 · Received April 13, 2021

    Report

    Report Number
    3010536692-2021-00203
    Event Type
    Injury
    Date Received
    April 13, 2021
    Report Date
    April 13, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(6). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. DEVICES FROM A DIFFERENT MANUFACTURER: V40 MODULAR HEAD PRODUCT ID: 6260-9-036, LOT: MJHAT9. EXETER V40 STEM PRODUCT ID: 5801501, LOT: G3336126. (B)(6) REFERENCE NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552348 RIM-LOCK HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHA04612 1434342

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention