MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT; HIP DISTAL STEM

Catalog Number	01.22.104
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 march 2024.Lot: 2007038: (b)(4) items manufactured and released on 11-jan-2021.Expiration date: 2025-dec-08.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 implants.Batch review performed on 6 march 2024 on stem: m-vizion 01.22.401 proximal body ø20mm l 40mm std with holes (k201471) lot.2115466.Lot: 2115466: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 2027-feb-27.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.Batch review performed on 6 march 2024 on ball heads: cocr 01.25.014 cocr ball head 12/14 ø 28 size xl +7 (k072857) lot.1903463.Lot: 1903463: (b)(4) items manufactured and released on 08-oct-2019.Expiration date: 2024-sep-25.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) 2023.On (b)(6) 2023, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised competitor cup and liner and medacta head.The surgery was completed successfully.On (b)(6) 2023, the patient came due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the medacta head and competitor liner.The surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed the medacta stem and head and competitor cup and liner and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT
• Common Device Name: HIP DISTAL 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: 18985247
• Report Number: 3005180920-2024-00152
• Device Sequence Number: 8381901
• Product Code: LZO
• UDI-Device Identifier: 07630030885013
• UDI-Public: 07630030885013
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/27/2024

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 Expiration Date: 12/08/2025
• Device Catalogue Number: 01.22.104
• Device Lot Number: 2007038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2021
• 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 Age: 62 YR
• Patient Sex: Female