MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM LAT; CEMENTLESS STEM PROXIMAL BODY

Model Number	01.22.009
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 january 2022.Lot 155513a: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-aug-29.No anomalies found related to the problem.To date, only this item of this lot has been sold.Additional implant involved: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.2006677.Batch review performed on 28 january 2022.Lot 2006677: (b)(4) items manufactured and released on 07-oct-2020.Expiration date: 2025-sep-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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 1 month after the primary surgery, the surgeon performed a washout and revised the head and proximal body.The surgery was completed successfully.

• Brand Name: STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM LAT
• Common Device Name: CEMENTLESS STEM PROXIMAL BODY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13505007
• Report Number: 3005180920-2022-00121
• Device Sequence Number: 11698407
• Product Code: LZO
• UDI-Device Identifier: 07630030885136
• UDI-Public: 07630030885136
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2022
• 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): 02/10/2022

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: 08/29/2026
• Device Model Number: 01.22.009
• Device Catalogue Number: 01.22.009
• Device Lot Number: 155513A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• 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 Sex: Male