MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES; HIP STEM WITH STD WITH HOLES

Model Number	01.22.403
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 august 2022: lot 2007094: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-apr-21.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 implanted component.Batch review performed on 19 august 2022 on stem: m-vizion 01.22.139 distal stem ø20mm l 180mm straight (k191816) lot.1901239.Lot 1901239: (b)(4) items manufactured and released on 21-oct-2019.Expiration date: 2026-apr-21.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 came in reporting pain due to a subsided stem and the cause is unknown.The surgeon revised the proximal body, head, and liner 5 months after the primary surgery.The surgery was completed successfully.

• Brand Name: STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES
• Common Device Name: HIP STEM WITH STD WITH HOLES
• 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: 15258829
• Report Number: 3005180920-2022-00628
• Device Sequence Number: 6614099
• Product Code: LZO
• UDI-Device Identifier: 07630971263529
• UDI-Public: 07630971263529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/19/2022

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: 04/21/2026
• Device Model Number: 01.22.403
• Device Catalogue Number: 01.22.403
• Device Lot Number: 2007094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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