MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD; HIP REVISION CEMENTLESS MODULAR STEM

Model Number	01.22.005
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2021: lot 1901214: (b)(4) items manufactured and released on 11-feb-2020.Expiration date: 2025-01-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional device involved batch review performed on 30 april 2021: stem: m-vizion 01.22.161 distal stem ø12mm l 220mm straight (k191816) lot 1901248: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed 3 months after the primary due to subsidence of proximal and distal part of the stem.The surgeon successfully revised the proximal body, distal stem, option head, and option sleeve with competitor components.

• Brand Name: STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD
• Common Device Name: HIP REVISION CEMENTLESS MODULAR STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11831978
• Report Number: 3005180920-2021-00412
• Device Sequence Number: 17220355
• Product Code: LZO
• UDI-Device Identifier: 07630971240834
• UDI-Public: 07630971240834
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 05/17/2021

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: 01/28/2025
• Device Model Number: 01.22.005
• Device Catalogue Number: 01.22.005
• Device Lot Number: 1901214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR