BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE® BFH® HEAD 46MM MEDIUM NECK

    MDR report key: 15365902 · Received September 6, 2022

    Report

    Report Number
    3010536692-2022-00318
    Event Type
    Injury
    Date Received
    September 6, 2022
    Report Date
    November 10, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    UDI-DI
    M684380146001
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY. PRODUCTS NOT REVISED: 1-PRODUCT ID: PHA00240, PROFEMUR® Z FEMORAL STEM SIZE 5 CEMENTLESS, LOT NUMBER: NI, QTY: 1. 2-PRODUCT ID: PHA01202, PROFEMUR® NECK NEUTRAL SHORT, LOT NUMBER: NI, QTY: 1.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: 4914788 SIDE:R PRIMARY ASA: P1 - FIT AND HEALTHY PRODUCTS NOT REVISED: 1-PRODUCTID: PHA00240, PROFEMUR® Z FEMORAL STEM SIZE 5 CEMENTLESS, LOT NUMBER: 058595929, QTY: 1. 2-PRODUCTID: PHA01202, PROFEMUR® NECK NEUTRAL SHORT, LOT NUMBER: 048583129, QTY: 1. ADDITIONAL INFORMATION RECEIVED ON 9/15/2022: IT WAS STATED FROM UK NJR THAT THIS LOOKS TO BE A SAME DAY BILATERAL SO THERE ARE TWO SETS OF IMPLANTS. HOWEVER, ONE SET OF IMPLANTS REGARDING PRIMARYPROCEDUREID # 612754 HAS AN UNREVISED STATUS. REVIEW OF INITIAL DOCUMENTATION PROVIDED FROM NJR (EXCEL DOCUMENT) CONFIRMS THAT THE SET OF IMPLANTS REGARDING PRIMARYPROCEDUREID # 612754 ARE NOT REVISED. EXCEL DOCUMENT SHOWS NO ALLEGED COMPLAINT AGAINST THE UNREVISED IMPLANTS. UNREVISED PRODUCTS FOR PRIMARYPROCEDUREID # 612754 ARE: 1-PRODUCTID: PHA00240, PROFEMUR® Z FEMORAL STEM SIZE 5 CEMENTLESS, LOT NUMBER: 058608693, QTY: 1. 2-PRODUCTID: PHA01232, PROFEMUR® MODULAR FEMORAL NECK, LOT NUMBER: 048577534, QTY: 1 3-PRODUCTID: 38HA4652, CONSERVE® THIN SHELL HA COATED 46MM ID 52MM OD BEADED, LOT NUMBER: 018480873, QTY: 1. 4-PRODUCTID: 38014600, CONSERVE® BFH® HEAD 44MM MEDIUM NECK, LOT NUMBER: 068605243, QTY: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618339 CONSERVE® BFH® HEAD 46MM MEDIUM NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 38014600 068605243 M684380146001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention