BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4

    MDR report key: 12452040 · Received September 10, 2021

    Report

    Report Number
    3005180920-2021-00726
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 AUGUST.2021: LOT 180761: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JUNE 2018. EXPIRATION DATE: 2023-JUNE-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION DUE TO LOOSE STEM 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349629 STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4 FEMORAL COMPONENT LZO MEDACTA INTERNATIONAL SA 01.18.134 180761 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention