BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1

    MDR report key: 16204987 · Received January 19, 2023

    Report

    Report Number
    3005180920-2022-01011
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    December 28, 2022
    Report Date
    January 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720007
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 DECEMBER 2022. LOT 182521: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JULY-2018. EXPIRATION DATE: 2023-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393723 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1 HIP STEM NON CEMENTED LZO MEDACTA INTERNATIONAL SA 01.18.401 182521 07630040720007

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention