BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 23669494 · Received November 28, 2025

    Report

    Report Number
    3005180920-2025-01191
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    November 11, 2025
    Report Date
    November 28, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720014
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2025. STEM: AMISTEM P 01.18.402 AMISTEM-P STD. SIZE 2 (K173794) LOT 1903222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 07-JUL-2024. 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 01.29.204 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S (K112115) LOT 1810793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 18-FEB-2024. 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 01.32.150DH ACETABULAR SHELL D 50 TWO-HOLES (K132879) LOT 1905334: (B)(4) TEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 14-SEP-2024. 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 01.32.3241HCT FLAT PE HC LINER D 32/D (K103721) LOT 1905497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 15-JUN-2024. 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

    AT ABOUT 5 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND PUT IN COMPETITOR SPACERS WITH ANTIBIOTIC CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229116 AMISTEM-P AMISTEM-P STD. SIZE2 LZO MEDACTA INTERNATIONAL SA 01.18.402 1903222 07630040720014

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention