BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK

    MDR report key: 11568319 · Received March 25, 2021

    Report

    Report Number
    3005180920-2021-00239
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802621
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 MARCH 2021: LOT 1905427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464874 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.22SN 1905427 07630030802621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention