MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION DISTAL STEM 13MM L 180MM STRAIGHT

Model Number 01.22.132

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 23 november 2020.Lot#: 1901232: (b)(4) items manufactured and released on 8-nov-2019.Expiration date: 2024-10-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: during post-infection revision tha in a patient with very weak bone, the femoral shaft is fractured, and a false route is taken by the femoral stem.This adverse event is to be related with the patient condition, and is not due to a defective device.

Event Description

The primary surgery was performed on (b)(6) 2020.After the surgery(the same day), the surgeon checked and discovered the tip of the femoral stem protruded from the medullary cavity at x-ray.The bone fracture occurred during the primary surgery.The surgeon replaced the stem with new one.The anterior curvature was taken in account during the planning.The trial phase was performed but the x-ray was not taken in this phase.The surgeon used posterior approach and done reaming manually (13 mm size).The size of the used components was the same as during planning and no deviation from the surgery technique was done.The bone of the patient was weak, previously this patient had a revision due to infection(competitor implants), and this implants were replaced with cement mold.

• Brand Name: STEM: M-VIZION DISTAL STEM 13MM L 180MM STRAIGHT
• Type of Device: DISTAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10983317
• MDR Text Key: 220670626
• Report Number: 3005180920-2020-00881
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040728904
• UDI-Public: 07630040728904
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 01.22.132
• Device Catalogue Number: 01.22.132
• Device Lot Number: 1901232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention