BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 22894259 · Received August 26, 2025

    Report

    Report Number
    3005180920-2025-00807
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040720120
    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 06 AUGUST 2025 STEM: AMISTEM P 01.18.413 AMISTEM-P LAT. #3 (K173794) LOT. 2403882: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUNE-2024. EXPIRATION DATE: 03-JUNE-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. ADDITIONAL DEVICES ALSO REVISED: BALL HEADS: MECTACER 01.29.210 36 MM BIOLOX DELTA HEAD L (K112115) LOT. 2430511: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-NOV-2024. EXPIRATION DATE: 03-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. MPACT 01.32.158 DHT ACETABULAR SHELL Ø58 TWO-HOLES T (K230011) LOT. 2431475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2025. EXPIRATION DATE: 28-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. SCREW: MPACT 3D METAL ILIAC SCREW 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L25(K200391) LOT. 2431117 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2025. EXPIRATION DATE: 10-DEC-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. SCREW: MPACT 3D METAL ILIAC SCREW 01.43.0035 CANCELLOUS BONE SCREW Ø 6,5 L35 (K200391) LOT. 2413348: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 -JULY-2024. EXPIRATION DATE: 30-JUNE-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: MECTACER 01.32.3652 HCT FLAT PE HC LINER Ø36/G (K103721) LOT. 2430447: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 -JAN-2025. EXPIRATION DATE: 16 -DEC -2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A 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 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION WITH AN UNKNOWN CAUSE. THE IMPLANTS WERE REMOVED AND REPLACED WITH A COMPETITOR ANTIBIOTIC CEMENT SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630762 AMISTEM-P AMISTEM-P LAT. SIZE 3 LPH MEDACTA INTERNATIONAL SA 01.18.413 2403882 07630040720120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention