MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; MONOBLOCK STEM Ø14MM L 290MM STD

Model Number	01.22.643
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for m-vizion monoblock subsidence at 5 months from primary.The patient had pain and a stem subsidence was recognized during a follow up visit.The head was revised successfully to a longer head and the stem was not revised.
Additional Manufacturer Narrative
Batch review performed on 20 february 2025: lot 2236070: (b)(4) items manufactured and released on 22-03-2023.Expiration date: 2028-02-28.No anomalies found related to the problem.To date, no other device of this batch have been sold.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.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: MONOBLOCK STEM Ø14MM L 290MM STD
• 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: 21420283
• Report Number: 3005180920-2025-00107
• Device Sequence Number: 7642358
• Product Code: LZO
• UDI-Device Identifier: 07630345707758
• UDI-Public: 07630345707758
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K212327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/20/2025

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: 01.22.643
• Device Lot Number: 2236070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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: 68 YR
• Patient Sex: Male