MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; M-VIZION PROXIMAL BODY Ø20MM L 60MM LAT WITH HOLES

Model Number	01.22.409
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: a re-revision procedure was performed five months after the initial revision surgery, due to evidence of stem mobilization and subsidence.The pre-revision radiograph, being a modified image intended for surgical planning, offers limited value for detailed clinical assessment.Nevertheless, stem subsidence appears to be confirmed.The immediate post-operative radiograph, although of suboptimal quality, does not reveal any obvious complications; notably, the distal fixation of the stem beyond the fracture site appears adequate.Identifying the precise cause of failure remains difficult based on the available data.However, the poor bone quality observed in the images may have contributed to the outcome.At this stage, no definitive conclusions can be drawn.Batch review performed on 16 may 2025: lot 2347471: (b)(4) items manufactured and released on 07/05/2024.Expiration date: 23/04/2029.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 device involved: batch review performed on 16 may 2025: stem: m-vizion 01.22.501 distal stem ø12mm l 140mm straight 4 degree (k092076) lot 2103669: (b)(4) items manufactured and released on 20/08/2021.Expiration date: 29/06/2026.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, although it is possible that factors such as low bone quality may have contributed to the event.Although no root cause can be confirmed, the investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
About 5 months after the first revision surgery, another revision surgery was performed due to secondary movement and subsidence.The patient has a first revision surgery (on (b)(6) 2025) due to a periprosthetic femoral fracture caused by a fall (primary surgery was performed in (b)(6) 2013).Pseudoarthrosis of the fracture borders is currently present, especially around the greater trochanter and istmus region of the femur.M-vizion stem removed without further difficulties and replaced with competitor revision shaft (corail revision), partial reopening of fracture area, new cerclages, and proximal femoral plate placed to stabilize the fracture around the isthmus and greater trochanter.Versafit dm cup is stable and has good placement in the acetabulum, so it was left in situ.Liner and head replaced with the same sizes.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: M-VIZION PROXIMAL BODY Ø20MM L 60MM 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: 22175023
• Report Number: 3005180920-2025-00515
• Device Sequence Number: 15408460
• Product Code: LZO
• UDI-Device Identifier: 07630971263581
• UDI-Public: 07630971263581
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K201471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/10/2025

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: 01.22.409
• Device Lot Number: 2347471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 50 KG