MAUDE Adverse Event Report: Medacta International SA AMIStem C Femoral Stems; AMIStem-C Std. size 2

Model Number	01.18.152
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed at 20 days from primary due to femoral stem subsidence.Stem, head and liner successfully revised.
Additional Manufacturer Narrative
Batch review performed on 22 jul 2026 lot 2435536: (b)(4) items manufactured and released on 04/04/2025.Expiration date: 12/03/2030.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.Root cause:implant subsidence is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.The event appears multifactorial and may be related to loss or lack of stem fixation/osseointegration, patient or surgical factors.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: AMIStem C Femoral Stems
• Common Device Name: AMIStem-C Std. size 2
• 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: 50114126
• Report Number: 3005180920-2026-00794
• Device Sequence Number: 17509943
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 01.18.152
• Device Lot Number: 2435536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2025
• 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 Age: 73 YR
• Patient Sex: Female