MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; DISTAL STEM Ø17MM L 140MM STRAIGHT

Model Number	01.22.106
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 8 months after the primary, the patient came in reporting pain due to a subsided stem and the cause is unknown.The surgeon revised the stem and head and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 october 2025.Stem: m-vizion 01.22.106 distal stem ø17mm l 140mm straight lot.2101129 (k170690): (b)(4) items manufactured and released on 23-july-2021.Expiration date: 2026-07-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Stem: m-vizion 01.22.401 proximal body ø20mm l 40mm std with holes lot.2247722 (k170690) lot 2247722: (b)(4) items manufactured and released on 29-march-2023.Expiration date: 2028-03-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: 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.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: DISTAL STEM Ø17MM L 140MM STRAIGHT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23477198
• Report Number: 3005180920-2025-01063
• Device Sequence Number: 21389182
• Product Code: LZO
• UDI-Device Identifier: 07630030885037
• UDI-Public: 07630030885037
• Combination Product (Y/N): N
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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 Expiration Date: 07/12/2026
• Device Model Number: 01.22.106
• Device Lot Number: 2101129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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: Female
• Patient Race: White