MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; STEM: M-VIZION DISTAL STEM Ø14MM L 140MM STRAIGHT

Model Number	01.22.103
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month from primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14-02-2025: lot 2101126: (b)(4) items manufactured and released on 23-07-2021.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 event during the period of review.Additional devices involved batch reviews performed on 14-february-2025: m-vizion 01.22.422 proximal body ø24mm l 50mm std with holes (k201471) lot 2010787: (b)(4) items manufactured and released on 11-01-2022.Expiration date: 2026-12-15.No anomalies found related to the problem.To date, 14 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 2422261: (b)(4) items manufactured and released on 03-09-2024.Expiration date: 2029-08-20.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 01.32.3648hct flat pe hc liner ø36/f (k103721) lot 2406333: (b)(4) items manufactured and released on 05-04-2024.Expiration date: 2029-03-21.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 3d metal 01.38.358mh mpact 3d metal shell multi hole thin ø58mm (k202568) lot 2338689: (b)(4) items manufactured and released on 13-12-2023.Expiration date: 2028-11-28.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.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: STEM: M-VIZION DISTAL STEM Ø14MM 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: 21503345
• Report Number: 3005180920-2025-00146
• Device Sequence Number: 4400866
• Product Code: LZO
• UDI-Device Identifier: 07630030885006
• UDI-Public: 07630030885006
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 01.22.103
• Device Lot Number: 2101126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Race: White