MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.TF2.LM TIBIAL TRAY FIX CEMENTED S2 LM; KNEE TIBIAL TRAY CEMENTED

Model Number	02.18.TF2.LM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the primary knee surgery, after the moto femur, insert and tibia were implanted the surgeon performed a range of motion control and an excessive tibial baseplate movement, along the x-axis, was observed.Due to this, the surgeon decided to convert the uka to tka, probably due to the fact that he may have felt the tibial preparation led to the tibia too medial and structurally compromised and unable to support uka.This decision, to convert to tka, extended the case roughly 20-25 minutes.
Additional Manufacturer Narrative
Batch review performed on 22-jun-2022 lot 2109990: (b)(4) items manufactured and released on 19-oct-2021.Expiration date: 2026-10-05.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.TF2.LM TIBIAL TRAY FIX CEMENTED S2 LM
• 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: 14776852
• Report Number: 3005180920-2022-00478
• Device Sequence Number: 11969973
• Product Code: HSX
• UDI-Device Identifier: 07630030896712
• UDI-Public: 07630030896712
• 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
• 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): 06/22/2022

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: 10/05/2026
• Device Model Number: 02.18.TF2.LM
• Device Catalogue Number: 02.18.TF2.LM
• Device Lot Number: 2109990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• 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: Other
• Patient Sex: Female