MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM-H STD. SIZE 1

Model Number	01.18.131
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 years and 7 months from the primary, the patient came in due to pain related to a loose stem and the cause is unknown.There were no signs of trauma.The surgeon swapped the medacta head and stem for a competitor head and stem and swapped the medacta liner for a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: 10 years after primary cementless tha, areas of progressive bone rarefaction are visible on the one x-ray supplied.Origin unknown.The result is a progressively loose stem that requires exchange.No other significant findings were reported from the revision surgery.In the absence of trauma or infection, we must classify this event as a case of idiopathic aseptic loosening, which is one of the long-term adverse event that may occur after total joint arthroplasty.Batch review performed on 18 december 2025.Lot: 140745: (b)(4) items manufactured and released on 22-apr-2015.Expiration date: 29-feb-2020.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.Root cause:in the absence of trauma or infection, we must classify this event as a case of idiopathic aseptic loosening, which is one of the long-term adverse event that may occur after total joint arthroplasty.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM-H STD. SIZE 1
• 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: 23864305
• Report Number: 3005180920-2025-01314
• Device Sequence Number: 10006753
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 12/22/2025

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: 03/31/2019
• Device Model Number: 01.18.131
• Device Lot Number: 140745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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 Age: 77 YR
• Patient Sex: Female