MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD STEM SIZE 2

Model Number	01.18.432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: 2 years after cementless primary tha, at follow up examination the surgeon notices a slight cortical hyperthrophy in correspondence with the medial distal end of the femoral stem.No report of clinical problems.The stem was implanted in a slightly valgus position.This may be due to the anatomical shape of the femur or of the hip (we do not know as the preoperative images were not supplied) or it could be a slight deviation from the planned position.In either case, contact between the distal medial cortex and the tip of the stem is taking place, and naturally a significant fraction of the load is transmitted in that area, resulting in cortical hypertrophy.It is very likely that this finding, per se, will not create any clinical problem even in the long term.It is not due to a defect or malfunction of the implanted devices.Batch review performed on 23 september 2025 lot 2200406: (b)(4) items manufactured and released on 31-may-2022.Expiration date: 2027-05-16.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.Conclusions: 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
During a postoperative follow-up examination 2 years after primary, x-ray imaging revealed cortical hypertrophy at the distal portion of the stem.The patient remains under observation.No revision surgery is planned.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED STD STEM 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: 23310304
• Report Number: 3005180920-2025-00981
• Device Sequence Number: 5135160
• Product Code: LPH
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/16/2025

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: 01.18.432
• Device Lot Number: 2200406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian