MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P; AMISTEM-P STD. SIZE5

Model Number	01.18.405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed 1 year and 1 month after the primary surgery due to stem loosening caused by infection.The surgeon revised the stem and the liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 may 2026 lot 2417416: (b)(4) items manufactured and released on 02 september 2024.Expiration date: 29 july 2029.No anomalies were found to date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.Clinical evaluation one year after cementless primary tha, the stem becomes painful and needs replacement.The surgical team suspects infection; indeed, though there is no hard proof, the radiographic appearance at one year is certainly compatible with this hypothesis, because the proximal femur is not in contact with the stem any longer, and such an early behaviour of retraction shows incompatibility between host bone and implant, one of the consequences of infection.Correctly, the surgeon opted for a cemented stem as a replacement.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.
Additional Manufacturer Narrative
Fu1 d4: lot number: 2417413 d4: expiration date: 08/23/2029 h4: device manufacturer date: 09/03/2024 batch review: lot 2417413: (b)(4) items manufactured and released on 03 september 2024.Expiration date: 23 aug 2029.To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.

• Brand Name: AMISTEM-P
• Common Device Name: AMISTEM-P STD. SIZE5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25242298
• Report Number: 3005180920-2026-00437
• Device Sequence Number: 9490076
• Product Code: LZO
• UDI-Device Identifier: 07630040720045
• UDI-Public: 07630040720045
• Combination Product (Y/N): N
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.18.405
• Device Lot Number: 2417413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown