MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; DISTAL STEM Ø15MM L 180MM STRAIGHT

Model Number	01.22.134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 april 2025: lot 2339009: (b)(4) items manufactured and released on 05/03/2024.Expiration date: 06/02/2029.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 instrument involved, batch review performed on 29 april 2025: lot 2115471: (b)(4) items manufactured and released on 21/03/2022.Expiration date: 06/03/2027.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.It is most likely related to the unique patient/application specific conditions associated with this case, but the circumstances cannot be confirmed.The investigation results do not indicate any potential manufacturing issue.
Event or Problem Description
During the revision surgery due to pain, performed about 1 month and a half after the primary surgery, it was noted that the proximal body was retroverted.The proximal body would not disengage from the stem.An attempt and manual disengagement resulted in the entire construct extraction.The construct was then reinserted with the proper version.Reduction was difficult and resulted in a new distal femur fracture.All components were extracted including the non-medacta cup/liner.The case was then carried out with success with a new m-vizion stem and proximal body along with a medacta bipolar head construct.Fracture fixed.The surgery was completed successfully.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: DISTAL STEM Ø15MM 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: 22043492
• Report Number: 3005180920-2025-00436
• Device Sequence Number: 9018100
• Product Code: LZO
• UDI-Device Identifier: 07630040728928
• UDI-Public: 07630040728928
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K191816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.22.134
• Device Lot Number: 2339009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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; Other
• Patient Sex: Unknown