MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT

Model Number	01.22.102
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 september 2021: lot 2007036: (b)(4) items manufactured and released on 1-02-2021.Expiration date: 2026-01-21 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Other devices involved: batch review performed on 09 september 2021: stem: m-vizion 01.22.008 proximal body ø20mm l 50mm lat (k170690) lot 186406: (b)(4) items manufactured and released on 3-12-2019.Expiration date: 2024-11-23 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l (k112115) lot 2011682: (b)(4) items manufactured and released on 11-03-2021.Expiration date: 2026-02-21.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.
Event or Problem Description
1 month after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT
• Common Device Name: DISTAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12560085
• Report Number: 3005180920-2021-00785
• Device Sequence Number: 16530866
• Product Code: LZO
• UDI-Device Identifier: 07630030884993
• UDI-Public: 07630030884993
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170690
• 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): 10/01/2021

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: 01/21/2026
• Device Model Number: 01.22.102
• Device Catalogue Number: 01.22.102
• Device Lot Number: 2007036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 10/01/2021
• 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