MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM-H LAT. SIZE 3

Model Number	01.18.143
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation.12 years after primary cementless tha on a very young and very heavy male patient, the stem is losing proximal fixation and the surgeon decides to exchange it.Some signs of wear of the pe liner are visible in the radiograph, but we cannot determine the potential influence that this may have had on the revision procedure - in fact, there are no major visible areas of osteolysis and the bone quality seems to be still very good.The reason for the loosening cannot be determined with the information at hand, so we should classify it as idiopathic aseptic loosening.Batch review performed on 11 dec 2025.Stem: amistem h 01.18.143 amistem-h lat.Size 3 lot.131167: (b)(4) items manufactured and released on 05 june 2013.Expiration date: 30 april 2018.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:although a precise root cause cannot be established, the event can be classified as idiopathic aseptic loosening.There is no indication that any potential issue with the device caused or contributed to the event, and the review of the device history record did not identify any potential manufacturing-related issues.
Event or Problem Description
After 12 years and 3 months post-primary, the patient came in due to a potted stem.The surgery revised the stem, head, and liner.The surgery was completed successfully.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM-H LAT. SIZE 3
• 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: 23864347
• Report Number: 3005180920-2025-01287
• Device Sequence Number: 10006283
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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: 04/30/2018
• Device Model Number: 01.18.143
• Device Lot Number: 131167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2013
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Race: White