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

Model Number	01.22.005
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11.August.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 sold without any similar reported event.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.2010631.Batch review performed on 11.08.2021: lot 2010631: (b)(4) items manufactured and released on 3-feb-2021.Expiration date: 2026-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
2 months after the previous surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed the proximal body and head, performed a washout, and replaced the proximal body and head with new components.The surgery was completed successfully.Previously this patient had proximal body and head revision due to stem subsidence.

• Brand Name: STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD
• Common Device Name: CEMENTLESS PROXIMAL BODY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12390512
• Report Number: 3005180920-2021-00696
• Device Sequence Number: 17415150
• Product Code: LZO
• UDI-Device Identifier: 07630971240834
• UDI-Public: 07630971240834
• Combination Product (Y/N): N
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 08/04/2021
• Initial Report FDA Received Date: 08/31/2021
• 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