BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE® PLUS HA CUP

    MDR report key: 15364764 · Received September 6, 2022

    Report

    Report Number
    3010536692-2022-00317
    Event Type
    Injury
    Date Received
    September 6, 2022
    Report Date
    November 10, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIO B.5: ADDITIONAL INFORMATION IN DESCRIPTION / SECTION D.4: LOT# ADDED/ SECTION F.6: AWARENESS DATE HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    DUE TO HUMAN ERROR THE DOCUMENT WAS NOT ATTACH IN THE PREVIOUS REPORT.

    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-PRODUCTID: PHA00240, PROFEMUR® Z FEMORAL STEM SIZE 5 CEMENTLESS, LOT NUMBER: NI, QTY: 1. 2-PRODUCTID: 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
    2823873 CONSERVE® PLUS HA CUP HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 38HA4652 018480873

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention