MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.IF4.08.RM TIBIAL INSERT FIX S4 RM - 8MM; KNEE TIBIAL INSERT FIX

Model Number	02.18.IF4.08.RM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2104803: 21 items manufactured and released on 01-jul-2021.Expiration date: 2026-jun-16.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported event.
Event or Problem Description
The surgeon plans to exchange the existing 10mm tibial insert for a thicker one due to some varus/valgus instability.Revision surgery is planned for the (b)(6) 2022.

• Brand Name: MOTO PARTIAL KNEE 02.18.IF4.08.RM TIBIAL INSERT FIX S4 RM - 8MM
• Common Device Name: KNEE TIBIAL INSERT FIX
• 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, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14652251
• Report Number: 3005180920-2022-00439
• Device Sequence Number: 5720134
• Product Code: HSX
• UDI-Device Identifier: 07630030896101
• UDI-Public: 07630030896101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/10/2022

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: 06/16/2026
• Device Model Number: 02.18.IF4.08.RM
• Device Catalogue Number: 02.18.IF4.08.RM
• Device Lot Number: 2104803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• 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: Female