MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P; AMISTEM-P LAT. SIZE7

Model Number	01.18.417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 9 decemebr 2024.Lot 1900082d: (b)(4) items manufactured and released on 14-aug-2024.Expiration date: 28-jul-2029.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.A few days after primary cementless tha, the patient suffers a periprosthetic fracture on their femur, though reportedly no significant traumatic event occurred.Periprosthetic fractures are a rather common adverse event following tha; when they occur such a short time after the index surgery, it is conceivable that the preparation of the bone may have weakened it and therefore during rehabilitation the patient is more subject to fractures.There is no reason to suspect a defective or malfunctioning device behind this adverse event.Root cause:based on the available information, no definitive root cause can be established.The periprosthetic fracture of the femur occurred shortly after primary cementless tha, likely related to bone weakening from surgery and rehabilitation.There is no indication that the device contributed to the event, nor is there evidence of any manufacturing issue.
Event or Problem Description
At about 1 months from the primary, the patient came in reporting pain due to a bone broken femur distal to the medacta stem.The patient did not report any trauma.The surgeon cabled the fracture and revised the stem and head.The surgery was completed successfully.

• Brand Name: AMISTEM-P
• Common Device Name: AMISTEM-P LAT. SIZE7
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23858468
• Report Number: 3005180920-2025-01276
• Device Sequence Number: 18735547
• Product Code: LZO
• UDI-Device Identifier: 07630040720168
• UDI-Public: 07630040720168
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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 Model Number: 01.18.417
• Device Lot Number: 1900082D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2024
• 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 Sex: Male
• Patient Race: White