MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION PROXIMAL BODY Ø20MM L 70MM STD; HIP STEM PROXIMAL BODY

Model Number	01.22.004
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 2 months after the primary, revision surgery performed due to m-vizion stem subsidence.The surgeon revised successfully the proximal body (70 to 90 mm).
Additional Manufacturer Narrative
Batch review performed on 15-mar-2023.Lot 1901213: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision 1 year and 2 months after replacing a primary hip stem in a case periprosthetic fracture.For undetermined reasons, possibly due to the process of fracture healing or to insufficient initial pressfit of the stem, the femoral implant subsided significantly shortly after the operation and found secondary stability later on.As the distal part of the implant was well ostheointegrated the surgeon was able to reconstruct proper anatomic dimensions by substituting the proximal component only.No reason to suspect a defective device.

• Brand Name: STEM: M-VIZION PROXIMAL BODY Ø20MM L 70MM STD
• Common Device Name: HIP STEM PROXIMAL BODY
• 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: 16635896
• Report Number: 3005180920-2023-00223
• Device Sequence Number: 20620508
• Product Code: LZO
• UDI-Device Identifier: 07630971240827
• UDI-Public: 07630971240827
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/29/2023

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: 11/24/2024
• Device Model Number: 01.22.004
• Device Catalogue Number: 01.22.004
• Device Lot Number: 1901213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG