MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; M-VIZION DISTAL STEM Ø13MM L 140MM STRAIGHT

Model Number	01.22.102
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about two weeks, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06-05-2025: lot 2404594: (b)(4) items manufactured and released on 25-06-2024.Expiration date: 2029-06-12.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 devices involved batch review performed on 06-05-2025: m-vizion 01.22.403 proximal body ø20mm l 60mm std with holes (k201471) lot 2010776: (b)(4) items manufactured and released on 29-09-2021.Expiration date: 2026-09-15.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.Mectacer 01.29.210 mectacer head biolox delta dia.36 12/14-l (k112115 lot 2500710: (b)(4) items manufactured and released on 03-02-2025.Expiration date: 2030-01-13.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.Mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2430954: (b)(4) items manufactured and released on 28-01-2025.Expiration date: 2030-01-09.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.Impact 3d metal 01.38.354mh mpact 3d metal shell multi hole thin ø54mm (k202568) lot 2417813: (b)(4) items manufactured and released on 11-09-2024.Expiration date: 2029-08-27.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.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: M-VIZION DISTAL STEM Ø13MM L 140MM STRAIGHT
• 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: 22078242
• Report Number: 3005180920-2025-00476
• Device Sequence Number: 8397862
• Product Code: LZO
• UDI-Device Identifier: 07630030884993
• UDI-Public: 07630030884993
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170690
• 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): 05/23/2025

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: 01.22.102
• Device Lot Number: 2404594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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