MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COLLARED FEMORAL STEMS; AMISTEM COLLARED HA COATED STEM SIZE 1 STD

Model Number	01.18.231
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 9 years and 7 months from the primary, the patient came in reporting pain due to a potted stem and the cause is unknown.The surgeon revised the head, stem and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 november 2025.Stem: amistem h 01.18.231 amistem collared ha coated stem size 1 std lot 154530: (b)(4) items manufactured and released on 09-nov-2015.Expiration date: 31-oct-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.Clinical evaluation 9 years after primary cementless tha the stem is radiographically loose, for unknown reasons.In absence of evidence of an infection, we must categorize this event as idiopathic aseptic loosening, a possible adverse event following tha, described in literature, and whose causes often remain undetermined.Head and liner were exchanged as part of the routine procedure when the stem is exchanged, even though they were working properly.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint 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.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: AMISTEM H COLLARED FEMORAL STEMS
• Common Device Name: AMISTEM COLLARED HA COATED STEM SIZE 1 STD
• 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: 23836919
• Report Number: 3005180920-2025-01230
• Device Sequence Number: 14722695
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• Combination Product (Y/N): N
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/18/2025

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: 10/31/2020
• Device Model Number: 01.18.231
• Device Lot Number: 154530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White