MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.TF4.LM TIBIAL TRAY FIX CEMENTED S4 LM; KNEE TIBIAL TRAY

Model Number	02.18.TF4.LM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 weeks after the primary surgery, the patient came in reporting pain.The surgeon noticed from the x-rays a tibial plateau fracture through the keel.The surgeon used a plate and screws to fixate the patient and did not revise any implant.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10-jan-2023.Lot: 2112106: (b)(4) items manufactured and released on 22-dec-2021.Expiration date: 2026-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: MOTO PARTIAL KNEE 02.18.TF4.LM TIBIAL TRAY FIX CEMENTED S4 LM
• Common Device Name: KNEE TIBIAL TRAY
• 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, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16285532
• Report Number: 3005180920-2023-00014
• Device Sequence Number: 4942598
• Product Code: HSX
• UDI-Device Identifier: 07630030896750
• UDI-Public: 07630030896750
• 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): 02/02/2023

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 Model Number: 02.18.TF4.LM
• Device Catalogue Number: 02.18.TF4.LM
• Device Lot Number: 2112106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2021
• 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: Unknown