BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 12 V8D

    MDR report key: 14471443 · Received May 23, 2022

    Report

    Report Number
    3010536692-2022-00201
    Event Type
    Injury
    Date Received
    May 23, 2022
    Report Date
    May 23, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDI
    UDI-DI
    M684PLLES0121
    PMA / PMN Number
    K141235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY, THE PATIENT HAD FRACTURE OF FEMUR REVISED WITH NEW REVISION STEM. COMPONENTS NOT REVISED: PRODUCT: PRIME 60MM SHELL PRODUCT ID: P3SBQE60 LOT#: 1911347 QTY:1. PRODUCT: PRIME A-CLASS LINER GROUP E 36MM PRODUCT ID: P2LXSE36 LOT#: 1882594 QTY:1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343589 PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 12 V8D HIP COMPONENT JDI MICROPORT ORTHOPEDICS INC. PLLES012 1569721 M684PLLES0121

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention