BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 24020867 · Received January 9, 2026

    Report

    Report Number
    3005180920-2026-00034
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 9, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720212
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 JAN 2026. STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD. SIZE2(K173794) LOT. 2342288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 JAN 2024. EXPIRATION DATE: 07 JAN 2029. 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. LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER D 28/DMF (K0922659 LOT. 2339844: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 OCT 2023. EXPIRATION DATE: 11 OCT 2028. 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 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT. 2406489: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MARCH 2024. EXPIRATION DATE: 26 FEB 2029. 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. CUP: MPACT 01.32.152MB MPACT DM ACETABULAR SHELL D 52 (K143453) LOT. 2337845: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 FEB 2024. EXPIRATION DATE: 31 JAN 2029. 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 WAS PERFORMED 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION; THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85483 AMISTEM-P COLLARED AMISTEM-P COLLARED STD. SIZE2 LZO MEDACTA INTERNATIONAL SA 01.18.432 2342288 07630040720212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention