MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD STEM SIZE 5

Model Number	01.18.435
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-dec-2024.Lot 2406041: (b)(4) items manufactured and released on 19-jun-2024.Expiration date: 2029-06-06.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.During the postoperative follow-up x-ray, a periprosthetic fracture was detected following a tha.The available x-ray images reveal a fracture line located distal to the apex of the stem.It is reported that the surgeon believes the complication occurred during the stem impaction phase.Intraoperative femoral fractures are known potential adverse events in tha, as described and quantified in the literature.These complications are mainly influenced by factors such as bone morphology, mechanical properties, and the selected size/positioning of the implant.In this case, the femoral cut appears to be high, and the chosen stem size, intended to fill the proximal part of the femur, may have been slightly oversized for the femoral canal.We do not have reasons to suspect a defective or malfunctioning device.
Event or Problem Description
After the surgery, while viewing the post operative x-rays, a femoral bone fracture below the stem was noticed.It is likely that the fracture occurred during the surgery, probably during the impaction of the stem.The patient will be monitored and after 6 weeks a ct scans for a check will be performed.Revision surgery is not planned at the moment.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED STD STEM SIZE 5
• 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: 21033589
• Report Number: 3005180920-2024-01119
• Device Sequence Number: 17161428
• Product Code: LPH
• UDI-Device Identifier: 07630040720243
• UDI-Public: 07630040720243
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/30/2024

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: 01.18.435
• Device Lot Number: 2406041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• 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: 69 YR
• Patient Sex: Male