BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM

    MDR report key: 16726770 · Received April 12, 2023

    Report

    Report Number
    3010536692-2023-00072
    Event Type
    Injury
    Date Received
    April 12, 2023
    Report Date
    May 15, 2023
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    UDI-DI
    M68438AM40351
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ALREADY CAPTURED UNDER 21110058, DUE TO THIS IS A DUPLICATE INCIDENT, PLEASE VOID THE FOLLOWING REPORT.

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    ALLEGEDLY, ON OR ABOUT (B)(6) 2021, PLAINTIFF REPORTED FOR A REVISION/REPLACEMENT IF THE FEMORAL HEAD AND NECK. DR RECOMMENDED THE REVISION SURGERY AFTER PLAINTIFF PRESENTED WITH PAIN AND WEAKNESS, ADVERSE LOCAL TISSUE REACTION AND ELEVATED COBALT LEVELS. NECK (PHA01242), HEAD (PHA04426), AND LINER (DLXPLF40) WERE IMPLANTED DURING THE REVISION SURGERY. PRODUCTS NOT REVISED: PRODUCT ID: LOT NUMBER: QTY: 20070031 1830209 1. DSPCGF56 1822203 1. PHA00248 01112839031803042 1. 18080304 1771974 1. 18080303 1802295 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107887 CONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 38AM4035 05113488501805518 M68438AM40351

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention