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

Model Number	01.18.462
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-may-2025: lot 2415527: (b)(4) items manufactured and released on 24-oct-2024.Expiration date: 02-oct-2029.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 2 weeks after primary, the patient came in reporting pain and a periprosthetic bone fracture was confirmed.The surgeon revised successfully the stem.

• Brand Name: AMISTEM-P SHORT NECK
• Common Device Name: AMISTEM P SHORT NECK 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: 22087872
• Report Number: 3005180920-2025-00478
• Device Sequence Number: 7866535
• Product Code: LZO
• UDI-Device Identifier: 07630971243668
• UDI-Public: 07630971243668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: 01.18.462
• Device Lot Number: 2415527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian