MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; DISTAL STEM Ø16MM L 140MM STRAIGHT

Model Number	01.22.105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent primary and revision surgery on the same day.During the primary procedure, the surgeon noted that the bone and cement appeared to push the implant in an anterolateral direction, though it initially seemed acceptable.After surgery, while the patient was in the post-anesthesia care unit, a postoperative x-ray showed that the stem had perforated the bone.Poor bone quality was also observed.All components revised.
Additional Manufacturer Narrative
Batch review performed on 17 feb 2026.Stem: m-vizion 01.22.105 distal stem d 16mm l 140mm straight (k170690) lot 2429917: 20 items manufactured and released on 03-feb-2025.Expiration date: 15-jan-2030.No anomalies found related to the problem.To date, 11 items of the same lot have been sold with no similar reported event during the period of review.Stem: m-vizion 01.22.429 proximal body d 24mm l 60mm lat with holes (k201471) lot 2010794: 40 items manufactured and released on 19-aug-2021.Expiration date: 22-jul-2026.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director.During preparation of the femoral canal in total hip arthroplasty (tha), a femoral perforation occurred.The complication was identified only after wound closure, requiring a reoperation.Radiographic images suggest that the acetabular cup may be oversized and possibly positioned in a suboptimal orientation; however, additional radiographic projections would be necessary to properly assess the implant positioning.Femoral perforation is a known potential intraoperative complication of tha and is described in the instructions for use.Based on the available information, it is not plausible that this event was caused by a defective or malfunctioning device.Root cause:femoral perforation is a known potential intraoperative complication of total hip arthroplasty.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: DISTAL STEM Ø16MM 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: 24558194
• Report Number: 3005180920-2026-00173
• Device Sequence Number: 9330717
• Product Code: LZO
• UDI-Device Identifier: 07630030885020
• UDI-Public: 07630030885020
• Combination Product (Y/N): N
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/10/2026

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: 01.22.105
• Device Lot Number: 2429917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2025
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White