MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C FEMORAL STEMS; AMISTEM C CEMENTED STEM LATERALIZED SIZE 2

Model Number	01.18.102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation.One week after a cemented total hip arthroplasty, the patient reported acute pain following a leg movement while sitting in a chair.A subsequent x-ray revealed a periprosthetic femoral fracture in the calcar region.This type of movement, combined with bone weakening normally resulting from standard femoral preparation, may have contributed to the occurrence of the early fracture.There is no indication to suspect a defect in the implant device.Batch review performed on 10-apr-2025.Lot 2010735: (b)(4) items manufactured and released on 18-jan-2021.Expiration date: 03-jan-2026.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.Conclusion: based on the information available no definitive root cause can be established, although it is possible that the movement combined with the bone weakening, normally resulting from femoral preparation, could have contributed to the event.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 1 week after the primary, the patient came in reporting pain due to a proximal femoral bone fracture, in particular the x-rays show a fracture of the medial calcar that extends inferiorly 3 cm from the lesser trochanter.It has been reported that the patient was moving her leg in a chair and heard a loud pop followed by pain.The surgeon cabled the fracture and revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: AMISTEM C FEMORAL STEMS
• Common Device Name: AMISTEM C CEMENTED STEM LATERALIZED 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: 21968606
• Report Number: 3005180920-2025-00275
• Device Sequence Number: 8142137
• Product Code: LZO
• UDI-Device Identifier: 07630030803802
• UDI-Public: 07630030803802
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/06/2025

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: 01/03/2026
• Device Model Number: 01.18.102
• Device Lot Number: 2010735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2021
• 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: Female