MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P; AMISTEM-P STD. SIZE3

Model Number	01.18.403
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in presenting pain due to a periprosthetic fracture resulting in a successive stem subsidence but the cause is unknown.There are no indications of trauma.At 21 days post primary the surgeon cabled the fracture and revised the amistem-p size 3 to a distal stem d 13mm l 140mm and revised the biolox 36mm head s to a biolox 36mm head m.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 may 2026: lot 2522223:(b)(4) items manufactured and released on 10-dec-2025.Expiration date: 2030-nov-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation performed by medacta medical affairs manager: a few days after primary cementless tha on a very heavy 88-year-old patient, a femoral periprosthetic fracture occurred and required substitution of the femoral stem.It is likely that the bone, stressed by surgical preparation during the primary procedure and further stressed by the heavy weight of the patient during rehabilitation, gave way.There is no reason to suspect a faulty device at the origin of this adverse event.Root cause:based on the information available, no definitive root cause can be established.The event may be related to case-specific clinical and biomechanical factors, including the patient¿s advanced age, high body weight, surgical bone preparation, and early post-operative loading.There is no indication that any potential device-related or manufacturing issue may have caused or contributed to the event.

• Brand Name: AMISTEM-P
• Common Device Name: AMISTEM-P 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: 25253490
• Report Number: 3005180920-2026-00489
• Device Sequence Number: 21468954
• Product Code: LZO
• UDI-Device Identifier: 07630040720021
• UDI-Public: 07630040720021
• Combination Product (Y/N): N
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/22/2026

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: 01.18.403
• Device Lot Number: 2522223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2025
• 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 Age: 88 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: White