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

Model Number	01.22.132
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: DISTAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10983317
• Report Number: 3005180920-2020-00881
• Device Sequence Number: 2975336
• Product Code: LZO
• UDI-Device Identifier: 07630040728904
• UDI-Public: 07630040728904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2024
• Device Model Number: 01.22.132
• Device Catalogue Number: 01.22.132
• Device Lot Number: 1901232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention