MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED LAT. SIZE 5

Model Number	01.18.445
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 august 2025.Lot 2426942: (b)(4) items manufactured and released on 03-march-2025.Expiration date: 05-feb-2030.No anomalies found related to the problem.To date, 24 items of the same lot have been sold with no similar reported event during the period of review.Conclusions: although a precise root cause cannot be established, the subsidence could be due to an occult fracture during the primary surgery, as reported by the surgeon, and the reason remains unknown.There is no evidence that the device caused or contributed to the event, and the device history record review revealed no manufacturing-related issues.
Event or Problem Description
After 15 days from the primary surgery, the patient came in reporting pain due to a subsided stem, and the cause is unknown.The surgeon revised the stem and head.The surgery was completed successfully.The surgeon isn't sure, but he suspects occult fracture at time of primary.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED LAT. SIZE 5
• 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: 22991999
• Report Number: 3005180920-2025-00859
• Device Sequence Number: 8868791
• Product Code: LPH
• UDI-Device Identifier: 07630040720342
• UDI-Public: 07630040720342
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 01.18.445
• Device Lot Number: 2426942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female