MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION PROXIMAL BODY Ø20MM L 80MM LAT WITH HOLES; HIP STEM

Model Number	01.22.411
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 april 2023.Lot 2010784: (b)(4) manufactured and released on 10-january-2022.Expiration date: 2026-12-15.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: we acknowledge the chronological history but we are unable to place the x-ray received.Therefore, more information is needed for the analysis to be completed.Additional involved implant: batch review performed on 13 april 2023 on liner: mpact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot.2238054 lot 2238054: (b)(4) manufactured and released on 02-nov-2022.Expiration date: 2027-10-11.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had competitor components and came in on (b)(6) 2023 for reasons unknown and the surgeon revised the competitor cup and liner with a medacta cup and liner, with the intention of revising the stem and head a week later.On (b)(6) 2023, the patient came back in and had the competitor stem and head revised with a medacta stem and head.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in for a post-op appointment and the surgeon determined that the patient's stem needed more revision.The surgeon put more anteversion in stem and changed the liner to an offset liner for more stability.The surgery was completed successfully.The patient was at risk of dislocation and had previous spine surgery.

• Brand Name: STEM: M-VIZION PROXIMAL BODY Ø20MM L 80MM LAT WITH HOLES
• 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: 16732296
• Report Number: 3005180920-2023-00265
• Device Sequence Number: 20510809
• Product Code: LZO
• UDI-Device Identifier: 07630971263604
• UDI-Public: 07630971263604
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201471
• 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): 04/13/2023

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 Model Number: 01.22.411
• Device Catalogue Number: 01.22.411
• Device Lot Number: 2010784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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