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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 293697686
• Report Number: 3005180920-2022-00439
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896101
• UDI-Public: 07630030896101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female