MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD. SIZE 2

Model Number	01.18.432
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2025.Lot 2422496: (b)(4) items manufactured and released on 18-nov-2024.Expiration date: 2029-11-03.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: three months after a primary uncemented tha in an elderly female patient, a periprosthetic bone fracture occurred at the distal end of the stem.No traumatic event was reported.The implants appeared to be well positioned and appropriately sized; therefore, it is likely that a minor traumatic event occurred, possibly unnoticed by the patient.The stem does not appear to have undergone any subsidence, although the postoperative x-ray was not provided, so this cannot be confirmed with certainty.The most probable cause of the adverse event is a minor trauma combined with bone fragility related to the patient's advanced age.There is no reason to suspect any defect in the devices.Conclusions: based on the information available, no definitive root cause can be established, while the device history record review does not indicate any potential manufacturing-related issue.Although it cannot be confirmed, the bone fracture could be related to stem subsidence combined with the patient's bone fragility.
Event or Problem Description
Stem subsidence causing femur fracture was found during a postoperative follow-up examination at 6 months from primary surgery; the patient reported a sense of discomfort.The fracture was managed with conservative treatment.The patient has poor bone quality.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED STD. SIZE 2
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 23290780
• Report Number: 3005180920-2025-00954
• Device Sequence Number: 4798194
• Product Code: LPH
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 01.18.432
• Device Lot Number: 2422496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian