MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; STEM: AMISTEM-P COLLARED 01.18.434 AMISTEM-P COLLARED STD STEM SIZE 4

Model Number	01.18.434
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 march 2025 lot 2418860: (b)(4) items manufactured and released on 04-nov-2024.Expiration date: 2020-oct-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 performed by medical affairs department: the complaint concerns a periprosthetic fracture that occurred the day after a total hip arthroplasty.The available x-ray image is of very poor quality and provides only a partial view of the affected hip, making a meaningful clinical evaluation impossible.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
A day after the primary hip surgery, the patient felt a pop after turning.The patient was perpendicular to his chair.He was going to sit in it, and he pivoted on the operative leg and went to sit down, and that is when he felt a pop in his leg.The surgeon observed the patient sustained a femur fracture.The surgeon revised the head and stem.The surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: STEM: AMISTEM-P COLLARED 01.18.434 AMISTEM-P COLLARED STD STEM SIZE 4
• 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: 21752455
• Report Number: 3005180920-2025-00259
• Device Sequence Number: 18682536
• Product Code: LPH
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• 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): 04/02/2025

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: 10/20/2020
• Device Model Number: 01.18.434
• Device Lot Number: 2418860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White