MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION DISTAL STEM Ø14MM L 180MM STRAIGHT; HIP CEMENTLESS STEM

Catalog Number	01.22.133
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-aug-2023: lot 1901233: (b)(4) items manufactured and released on 16-nov-2019.Expiration date: 2024-10-23.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 involved implant: batch review performed on 02-aug-2023 on stem: m-vizion 01.22.403 proximal body ø20mm l 60mm std with holes (k201471) lot.2010776.Lot 2010776: (b)(4) items manufactured and released on 29-sept-2021.Expiration date: 2026-09-15.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.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2023, the patient came in reporting pain due to a fractured femur due to falling.The surgeon revised the stem, head and liner and cabled the fracture.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to a subsided stem and the cause is unknown.The surgeon removed the stem and performed a girdlestone hip.The surgery was completed successfully.

• Brand Name: STEM: M-VIZION DISTAL STEM Ø14MM L 180MM STRAIGHT
• Common Device Name: HIP CEMENTLESS 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: 17489189
• Report Number: 3005180920-2023-00644
• Device Sequence Number: 15421793
• Product Code: LZO
• UDI-Device Identifier: 07630040728911
• UDI-Public: 07630040728911
• 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: 2023
• Device Explanted Year: 2023
• 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): 08/09/2023

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: 10/23/2024
• Device Catalogue Number: 01.22.133
• Device Lot Number: 1901233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2019
• 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