BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 12126626 · Received July 7, 2021

    Report

    Report Number
    3005180920-2021-00565
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 JUNE 2021. LOT 150841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MAY 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT SINCE 2017.

    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 MEDACTA STEM WITH A COMPETITOR STEM AND REVISED THE MEDACTA HEAD AND LINER WITH A MEDACTA HEAD AND LINER 5 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027373 STEM: AMISTEM H HA COATED STD STEM SIZE 1 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 150841 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention