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

Model Number	02.18.TF3.RM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 november 2021: lot 170792: (b)(4) items manufactured and released on 27-june-2017.Expiration date: 2022-06-06.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Another devices involved: batch review performed on 04 november 2021: moto partial knee 02.18.003rm anatomical femoral component cemented s3 rm (k162084) lot 1908730: (b)(4) items manufactured and released on 22-nov-2019.Expiration date: 2024-11-11.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported ev.Moto partial knee 02.18.If3.09.Rm tibial insert fix s3 rm - 9mm (k162084) lot 178558: (b)(4) items manufactured and released on 20-march-2018.Expiration date: 2023-03-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At 1 year 5 months after the primary the patient came in reporting flexion instability and the cause is unknown.The surgeon revised the patient to a total knee and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM
• Common Device Name: CEMENTED TIBIAL TRAY
• 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: 12867456
• Report Number: 3005180920-2021-00929
• Device Sequence Number: 11689458
• 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: 2020
• Device Explanted Year: 2021
• 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): 11/24/2021

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: 06/06/2022
• Device Model Number: 02.18.TF3.RM
• Device Catalogue Number: 02.18.TF3.RM
• Device Lot Number: 170792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2017
• 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