BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C FEMORAL STEMS

    MDR report key: 23334293 · Received October 20, 2025

    Report

    Report Number
    3005180920-2025-01034
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803789
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 OCTOBER 2025: STEM: AMISTEM C 01.18.100 AMISTEM-C LAT. # 0 (K103189) LOT. 2001472: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUNE-2020. EXPIRATION DATE: 15-JUNE-2025. 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 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT. 2500121: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2021. EXPIRATION DATE: 09-JAN-2030. 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 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 2429339: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-DEC-2024. EXPIRATION DATE: 17-NOV-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. CONCLUSIONS: 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

    AFTER 5 MONTHS, THE PATIENT CAME IN DUE TO AN INFECTION, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266879 AMISTEM C FEMORAL STEMS AMISTEM C CEMENTED STEM LATERALIZED SIZE 0 LZO MEDACTA INTERNATIONAL SA 01.18.100 2001472 07630030803789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention