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

Model Number	01.22.408
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); Unequal Limb Length (4534)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 march 2025.Lot 2409210: (b)(4) items manufactured and released on 09/09/2024.Expiration date: 20/08/2029.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.Additional item involved in the event: stem: m-vizion 01.22.134 distal stem ø15mm l 180mm straight (k191816) lot.2411112 lot 2411112: (b)(4) items manufactured and released on 16/07/2024.Expiration date: 04/07/2029.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.Root cause: the event was caused by a suboptimal selection of implant sizes during 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 potential manufacturing related issue.
Event or Problem Description
M-vizion stem was implanted on (b)(6) 2025.The patient needed to be revised because was experiencing pain, instability and leg length discrepancy, due to a too short proximal body implanted at the primary surgery.The revision surgery took place 1 month after the primary surgery and the plan was to revise only the proximal body.However, the disassembly rod bent during proximal stem extraction from the distal body.Despite the attempts, the proximal body could not be removed from the distal stem, therefore the surgeon decided to remove the entire stem (proximal + distal).The revision surgery was also treated with an m-vizion.Here, the surgeon chose a 16mm 180mm distal stem with a longer proximal body 20mm 70mm to compensate for the instability.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: 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: 21708063
• Report Number: 3005180920-2025-00242
• Device Sequence Number: 4682227
• Product Code: LZO
• UDI-Device Identifier: 07630971263574
• UDI-Public: 07630971263574
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: 2409210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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 Sex: Unknown