MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; M-VIZION PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES

Model Number	01.22.408
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21-jul-2025: stem: m-vizion 01.22.408 proximal body ø20mm l 50mm lat with holes (k201471) lot.2241140: (b)(4) items manufactured and released on 01-03-2023 expiration date: 2028-02-09.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.Stem: m-vizion 01.22.163 distal stem ø14mm l 220mm straight (k191816) lot.2007071: (b)(4) items manufactured and released on 15-03-2021 expiration date: 2026-02-23.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.The cause of the revision is reported to be specific device placement in the primary surgery.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 potentially related manufacturing issue.
Event or Problem Description
At about 1 week from primary the patient underwent revision surgery due to a malpositioning of the distal stem (falsa via).The entire construct has been revised.The two parts could not be separated as the tip of the screwdriver using during primary broke inside the locking screw.During the tightening of the locking screw the screw driver tip broke.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: M-VIZION PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES
• 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: 22643026
• Report Number: 3005180920-2025-00718
• Device Sequence Number: 8632303
• Product Code: LZO
• UDI-Device Identifier: 07630971263574
• UDI-Public: 07630971263574
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K201471
• 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): 07/29/2025

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: 01.22.408
• Device Lot Number: 2241140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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 Sex: Unknown