MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; 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	Medical device site infection (4845)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 july 2026 m-vizion 01.22.103 distal stem d 14mm l 140mm straight (k170690) lot.2337343: (b)(4) items manufactured and released on 31-jan-2024.Expiration date: 2029-jan-15.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.Mpact 01.26.2850mhc double mobility hc liner d 28/dme (k092265) lot.2421335: (b)(4) items manufactured and released on 17-sep-2024.Expiration date: 2029-sep-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Mectacer 01.29.202 mectacer head biolox delta dia.28 12/14-m (k112115) lot.2427352: (b)(4) items manufactured and released on 15-oct-2024.Expiration date: 2029-sep-29.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.Mpact 3d metal 01.38.062mh mpact 3d metal shell multi hole d 62mm (k171966) lot.2011329: (b)(4) items manufactured and released on 27-apr-2021.Expiration date: 2026-apr-19.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: 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.
Event or Problem Description
Revision surgery due to infection after about 1 year and 1 month from primary.The surgeon performed a washout, removed all implants and put in an antibiotic spacer.The surgery was completed successfully.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: DISTAL STEM Ø14MM 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: 25691665
• Report Number: 3005180920-2026-00635
• Device Sequence Number: 21193103
• Product Code: LZO
• UDI-Device Identifier: 07630030885006
• UDI-Public: 07630030885006
• Combination Product (Y/N): N
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 07/02/2026

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: 01.22.103
• Device Lot Number: 2337343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2024
• 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