MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES

Model Number	01.22.408
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 10 months from primary surgery, 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 29 july 2025: stem: m-vizion 01.22.408 proximal body ø20mm l 50mm lat with holes (k201471) lot.2010781: (b)(4) items manufactured and released on 02 aug 2021.Expiration date: 19 aug 2026.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.Additional implants revised, batch review performed on 29 july 2025: ball heads: cocr 01.25.023 crco ball head 12/14 ø 32size l +3.5 (k072857) lot.180326: (b)(4) items manufactured and released on 18 apr 2018.Expiration date: 10 apr 2023.No anomalies found related to the problem.Cup: mpact 01.32.150mh mpact multi hole cup 50mm (k132879) lot.2011718: (b)(4) items manufactured and released on 12 march 2021.Expiration date: 02 march 2026.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event during the period of review.Liner: mpact 01.32.3241hc10a face-changing 10° pe hc liner ø32/d(k183582) lot.1810848: (b)(4) items manufactured and released on 18 march 2019.Expiration date: 03 march 2024.No anomalies found related to the problem.Conclusions: 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.
Additional Manufacturer Narrative
Batch review performed on 29 july 2025: stem: m-vizion 01.22.408 proximal body ø20mm l 50mm lat with holes (k201471) lot.2010781: (b)(4) items manufactured and released on 02 sep 2021.Expiration date: 19 aug 2026.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.Additional implants revised, batch review performed on 29 july 2025: ball heads: cocr 01.25.023 crco ball head 12/14 ø 32size l +3.5 (k072857) lot.180326: (b)(4) items manufactured and released on 18 apr 2018.Expiration date: 10 apr 2023.No anomalies found related to the problem.Cup: mpact 01.32.150mh mpact multi hole cup 50mm (k132879) lot.2011718: 40 items manufactured and released on 12 march 2021.Expiration date: 02 march 2026.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event during the period of review.Liner: mpact 01.32.3241hc10a face-changing 10° pe hc liner ø32/d(k183582) lot.1810848: (b)(4) items manufactured and released on 18 march 2019.Expiration date: 03 march 2024.No anomalies found related to the problem.Conclusions: 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.Follow up - reason: - on 29 august 2025, we noticed that the manufacturing date (h4) of the m-vizion 01.22.408 proximal body ø20 mm l 50 mm lat with holes lot 2010781 was incorrect and we corrected it.- e4 corrected.
Event or Problem Description
At about 2 years and 10 months from primary surgery, 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.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: PROXIMAL BODY Ø20MM L 50MM 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: 22674986
• Report Number: 3005180920-2025-00754
• Device Sequence Number: 7533864
• Product Code: LZO
• UDI-Device Identifier: 07630971263574
• UDI-Public: 07630971263574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 08/19/2026
• Device Model Number: 01.22.408
• Device Lot Number: 2010781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2021
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Race: White