MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C IMPLANTS; AMISTEM-C STD. SIZE 1

Model Number	01.18.151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 september 2025: lot 188422: (b)(4) items manufactured and released on 15-jan-2019.Expiration date: 2023-12-19.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.Clinical evaluation performed by medacta medical affairs manager: 6 years after primary hybrid bilateral tha on a young woman, the diaphyses of the femur shows marked hypertrophy, even though the clinical report is not reported to be troublesome.The left side also shows a similar situation.The patient, in spite of the young age, shows extremely thin and weak proximal femoral bone on both sides.This is most probably what led the surgeon to choose cemented fixation for the stems at index surgery, a choice that we consider very wise and appropriate.The insufficient proximal bone quality resulted in marked stress shielding, but it was probably almost inevitable, given the peculiar condition of the patient.We do not see any reason to suspect a defective implant.There is no reason to suspect a faulty device.Conclusion: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
During a postoperative follow-up examination, x-ray imaging revealed cortical hypertrophy at the distal portion of the stem (right side).The patient remains under observation.The primary surgery was performed on (b)(6) 2019 (right side), (b)(6) 2019 (left side).

• Brand Name: AMISTEM C IMPLANTS
• Common Device Name: AMISTEM-C STD. SIZE 1
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 23289777
• Report Number: 3005180920-2025-00955
• Device Sequence Number: 17522881
• Product Code: LZO
• UDI-Device Identifier: 07630030804267
• UDI-Public: 07630030804267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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 Expiration Date: 12/19/2023
• Device Model Number: 01.18.151
• Device Lot Number: 188422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2019
• 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: Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian