BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 9983419 · Received April 21, 2020

    Report

    Report Number
    3010536692-2019-00949
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    August 1, 2019
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    UDI-DI
    M684PHA012021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENTS NOT REVISED : COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 52 PPR67352, LOT S05105284. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE PPR67510, LOT S05107050. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 11D PPR67604, LOT S05104470.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445250 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01202 S06108618 M684PHA012021

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention