MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P; AMISTEM-P STD. 6

Model Number	01.18.406
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 1 year and 4 months, the patient presented with pain related to a loose stem, and the cause is unknown.The surgeon diagnosed the stem as being “ potted, & rdquo; meaning it was distally fixed but loose proximally, creating a “ windshield wiper” effect.The surgeon revised the stem using a competitor implant and also revised the liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviewperformed on 10 october 2025.Lot 2308192: (b)(4) items manufactured and released on 13 july 2023.Expiration date: 27-june-2028.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: 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.

• Brand Name: AMISTEM-P
• Common Device Name: AMISTEM-P STD. 6
• 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: 23477170
• Report Number: 3005180920-2025-00942
• Device Sequence Number: 21381383
• Product Code: LZO
• UDI-Device Identifier: 07630040720052
• UDI-Public: 07630040720052
• Combination Product (Y/N): N
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/05/2025

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 Model Number: 01.18.406
• Device Lot Number: 2308192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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