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 Code	Aseptic loosening (4883)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery after 1 year and 2 months due to stem loosening that caused pain and instability.The surgeon revised the amistem-p collared size3 to a sms collared solid stem lat size11and revised the 36mm biolox head m to a 36mm biolox delta head l.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 09 september 2026 01.18.433 amistem-p collared std.Size3 lot.2433763: (b)(4)items manufactured and released on 24 march 2025.Expiration date: 09 march 2030.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:stem loosening may be influenced by case-specific clinical, biological, or mechanical factors; however, the available information is insufficient to identify a specific contributing factor.Implant mobilization 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.

• 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: 50692313
• Report Number: 3005180920-2026-00931
• Device Sequence Number: 9595239
• 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
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 2433763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2025
• 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: Unknown