BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM HA COATED LAT STEM SIZE 3

    MDR report key: 11236074 · Received January 27, 2021

    Report

    Report Number
    3005180920-2021-00070
    Event Type
    Injury
    Date Received
    January 27, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 27, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    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 05 JANUARY 2021: LOT 150141: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2017.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO POTTED STEM 5 YEAS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. STEM, HEAD AND LINER WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135745 STEM: AMISTEM HA COATED LAT STEM SIZE 3 FEMORAL STEM HA COATED CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.143 150141 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention