MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; DISTAL STEM Ø13MM L 180MM STRAIGHT

Model Number	01.22.132
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Medical device site infection (4845)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had an infection and the pathogen is unknown.At about 6 months from the primary the surgeon performed a wash out, and removed all implants, and implanted an antibiotic hip spacer.The surgery was successfully completed.
Additional Manufacturer Narrative
Batch reviews performed on 03 september 2025: stem: m-vizion 01.22.132 distal stem ø13mm l 180mm straight (k191816) lot: 2303781: (b)(4) items manufactured and released on 02-nov-2023.Expiration date: 2028-10-10.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: stem: m-vizion 01.22.403 proximal body ø20mm l 60mm std with holes (k201471) lot: 2115467: (b)(4) items manufactured and released on 22-mar-2022.Expiration date: 2027-03-06.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.Ball heads: mectacer 01.29.209 mectacer head biolox delta dia.36 (k112115) lot: 2430510: (b)(4) items manufactured and released on 15-nov-2024.Expiration date: 2029-nov-03.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.Liner: mpact 01.32.3648hct mpact flat liner hc 36/f l (k103721) lot: 2415572: (b)(4) items manufactured and released on 17-jun-2024.Expiration date: 2029-06-03.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.Cup: mpact 3d metal 01.38.356mh mpact 3d metal shell multi hole thin ø56mm (k202568) lot: 2212482: (b)(4) items manufactured and released on 4-aug-2022.Expiration date: 2027-07-17.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.Screws: mpact 01.43.0030 cancellous bone screw ø 6,5 l30 (k200391) lot: 2417197: (b)(4) items manufactured and released on 16-jul-2024.Expiration date: 2029-07-03.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.Screws: mpact 01.43.0030 cancellous bone screw ø 6,5 l30 (k200391) lot: 2423374: (b)(4) items manufactured and released on 25-sep-2024.Expiration date: 2029-09-11.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.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.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: DISTAL STEM Ø13MM L 180MM 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: 23063081
• Report Number: 3005180920-2025-00900
• Device Sequence Number: 9671053
• Product Code: LZO
• UDI-Device Identifier: 07630040728904
• UDI-Public: 07630040728904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191816
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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: 01.22.132
• Device Lot Number: 01.22.132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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