BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 23336123 · Received October 20, 2025

    Report

    Report Number
    3005180920-2025-01036
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720021
    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 09-OCT-2025. STEM: AMISTEM P 01.18.403 AMISTEM-P STD. SIZE 3 (K173794) LOT 2416538: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2024. EXPIRATION DATE: 04-JUL-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. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 2427360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2024. EXPIRATION DATE: 02-OCT-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 01.32.154DHT ACETABULAR SHELL Ø54 TWO-HOLES T (K230011) LOT 2401654 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2024. EXPIRATION DATE: 13-JUN-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 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2415572: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2024. EXPIRATION DATE: 03-JUN-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. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L30 (K200391) LOT 2423373:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2024. EXPIRATION DATE: 11-SEP-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 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE ENTIRE HIP SYSTEM WHILE UPSIZING THE HEAD, LINER AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452023 AMISTEM-P STEM: AMISTEM P STD. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.403 2416538 07630040720021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention