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

Catalog Number	01.22.134
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 august 2023.Lot 2006802: (b)(4) manufactured and released on 25-march-2021.Expiration date: 2025-12-16.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
During the primary hip surgery and during final torqueing of the m-vizion locking screw, the femur fractured distally.The surgeon was using antirotational handle 01.22.10.0154.Plate, screws and cables were placed to fix the fracture and the surgery was completed successfully.Poor patient's bone quality.

• Brand Name: M-VIZION DISTAL STEM Ø15MM L 180MM STRAIGHT
• Common Device Name: HIP DISTAL STEM
• 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: 17727779
• Report Number: 3005180920-2023-00702
• Device Sequence Number: 17777855
• Product Code: LZO
• UDI-Device Identifier: 07630040728928
• UDI-Public: 07630040728928
• 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: 2023
• 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): 09/12/2023

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: 12/16/2025
• Device Catalogue Number: 01.22.134
• Device Lot Number: 2006802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• 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 Sex: Female