MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD. SIZE3

Model Number	01.18.433
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 april 2026 stem: amistem-p collared 01.18.433 amistem-p collared std.Size 3 (k173794) lot 2418858: (b)(4) items manufactured and released on 24-oct-2024.Expiration date: 09-oct-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 one year after primary cementless tha the stem is loose and needs revision.The quality of the radiographic image is such that no conclusion can be drawn from its analysis.Apparently, the host bone never integrated the stem.This is probably a case of early idiopathic aseptic loosening, unexplained.We see no reason to suspect a faulty or defective device.Root cause: aseptic loosening is 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 and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
At about 1 year and 1 month from the primary, the patient came in presenting pain due to a loose stem and the cause is unknown.There was no indications of a fall or trauma.The surgeon revised the medacta stem and head to a competitor stem and head.The surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED STD. SIZE3
• 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: 25012251
• Report Number: 3005180920-2026-00361
• Device Sequence Number: 10462814
• Product Code: LZO
• UDI-Device Identifier: 07630040720229
• UDI-Public: 07630040720229
• 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: 2026
• 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): 04/28/2026

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: 01.18.433
• Device Lot Number: 2418858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2024
• 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