BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 8

    MDR report key: 19536389 · Received June 14, 2024

    Report

    Report Number
    3005180920-2024-00408
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720076
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-MAY-2024 LOT 2111609: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2021. EXPIRATION DATE: 2026-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 WEEK AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394770 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 8 HIP AMISTEM-P STD STEM LZO MEDACTA INTERNATIONAL SA 2111609 07630040720076

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention