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	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 30 jun 2025.Stem: amistem c 01.18.152 amistem-c std.Size 2 (k103189) lot.2421583: (b)(4) items manufactured and released on 04-oct-2024.Expiration date: 2029-09-20.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: the available x-ray images are preoperative and therefore, not relevant to the analysis of the event that occurred.Root cause: the device history record review does not indicate any potentially related manufacturing issue.Although no specific root cause can be confirmed, the issue experienced is likely related to the unique patient conditions and surgical application.
Event or Problem Description
During femur preparation with broach size 2, the amistem-c std.Size 2 remained sat up (8 mm) and could not be inserted.The stem was removed, the cement was removed using a drill, and a smaller size 0 was implanted.The surgery was completed successfully.Delay time 2 hours (total surgery time 6 hours).

• 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, 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: 22529151
• Report Number: 3005180920-2025-00682
• Device Sequence Number: 8028791
• Product Code: JDI
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.18.152
• Device Lot Number: 2421583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian