MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P; AMISTEM P LAT. SIZE 5

Model Number	01.18.415
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-june-2025: lot 1908462: (b)(4) items manufactured and released on 10-02-2020 expiration date: 2025-01-28.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 clinical affairs department: a revision surgery was performed four and a half years after the primary total hip arthroplasty (tha) due to aseptic stem loosening.Pre-revision radiographs revealed abnormal cortical remodeling in the proximal femur, particularly around the distal portion of the stem.The radiographic appearance raises the possibility of a periosteal reaction, although the underlying cause remains unclear.For example, no clinical or historical evidence of infection has been reported.Aseptic loosening is a well-documented complication in the literature, often with multifactorial or unclear etiology.Even in this case, the precise cause of the failure remains difficult to determine based on the available information.Aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
Patient underwent primary thr in 2020 and soon reported pain.During followup, xrays modification of the femural bone were noticed predicting a possible stem mobilization.On (b)(6) 2025, the stem was confirmed as mobilized and revised.M-vizion stem implanted and liner revised with dm converter to improve rom.Surgery completed successfully.

• Brand Name: AMISTEM-P
• Common Device Name: AMISTEM P LAT. 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: 22371285
• Report Number: 3005180920-2025-00580
• Device Sequence Number: 7918735
• Product Code: LZO
• UDI-Device Identifier: 07630040720144
• UDI-Public: 07630040720144
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 01/28/2025
• Device Model Number: 01.18.415
• Device Lot Number: 1908462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male