BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 24711035 · Received March 30, 2026

    Report

    Report Number
    3005180920-2026-00254
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 27, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720045
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MAR 2026. STEM: AMISTEM P 01.18.405 AMISTEM-P STD. SIZE5 (K173794) LOT. 2410442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JUN 2024. EXPIRATION DATE: 2029-JUNE-11. 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. BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT. 2427364: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 OCT 2024. EXPIRATION DATE: 2029-SEPT-29. 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. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY AFTER 1 YEAR AND 2 MONTHS FROM PRIMARY DUE TO PERIPROSTHETIC INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773901 AMISTEM-P AMISTEM-P STD. SIZE5 LZO MEDACTA INTERNATIONAL SA 01.18.405 2410442 07630040720045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention