MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM; KNEE TIBIAL TRAY CEMENTED

Model Number	02.18.TF3.RM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 november 2021.Lot 2009938: (b)(4).Expiration date: 2026-feb-17.No anomalies found related to the problem.(b)(4).
Event or Problem Description
During the primary knee surgery, when the surgeon was impacting the tibial baseplate final implant, the surgeon observed a tibial plateau fracture.It is unknown how the fracture occurred.The surgeon put a plate on the anterior aspect of the tibia and the surgery was completed successfully.There was a 15-minute delay and a consignment set was utilized.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• 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: 12878077
• Report Number: 3005180920-2021-00942
• Device Sequence Number: 14570870
• Product Code: HSX
• UDI-Device Identifier: 07630030896743
• UDI-Public: 07630030896743
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2021

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: 02/17/2026
• Device Model Number: 02.18.TF3.RM
• Device Catalogue Number: 02.18.TF3.RM
• Device Lot Number: 2009938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• 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