MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION MONOBLOCK STEM Ø16MM L 190MM LAT; HIP STEM

Catalog Number	01.22.705
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 august 2024.Lot 2341595: 19 items manufactured and released on 13-mar-2024.Expiration date: 2029-02-24.No anomalies found related to the problem.To date, 3 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department a revision surgery was performed four months after the implantation of a m-vizion monobloc stem due to stem subsidence.X-ray images clearly confirm the subsidence of the stem.The m-vizion stem had initially been implanted following a periprosthetic infection, which was treated with a two-stage procedure involving an extended trochanteric osteotomy.The bone remodeling process during the healing of the trochanteric fragment may have contributed to the stem's subsidence.This type of failure is well-documented, especially in the context of such complex surgeries, and can be attributed to several risk factors, including bone quality and lack of primary stability.We have no reason to suspect a defective or malfunctioning device.
Event or Problem Description
Revision surgery for m-vizion monoblock subsidence at about 4 months from a precedent revision surgery for infection.During the surgery the stem was found loose in the femur.Head and stem revised successfully.

• Brand Name: STEM: M-VIZION MONOBLOCK STEM Ø16MM L 190MM LAT
• Common Device Name: HIP 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: 20268111
• Report Number: 3005180920-2024-00740
• Device Sequence Number: 19667888
• Product Code: LZO
• UDI-Device Identifier: 07630345707925
• UDI-Public: 07630345707925
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K212327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/20/2024

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 Catalogue Number: 01.22.705
• Device Lot Number: 2341595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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: Unknown