MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R; KNEE TIBIAL TRAY CEMENTED

Model Number	02.12.T4I3R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 april 2023: lot 1907956: (b)(4) items manufactured and released on 21-jan-2020.Expiration date: 2025-jan-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 6 april 2023: gmk-revision 02.07.2403r femur revision ps size 3 r (k102437) lot 2108719: (b)(4) items manufactured and released on 11-oct-2021.Expiration date: 2026-sep-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.0310scf fixed tibial insert sc size 3/10mm (k103170) lot 2005182: (b)(4) items manufactured and released on 06-aug-2020.Expiration date: 2025-jul-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in reporting pain due to a capsule tear, dislocated patella, and subsided femur.The cause of this was unknown.The surgeon revised the femur and insert.The surgery was completed successfully.On (b)(6) 2023, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and implanted an antibiotics spacer.The surgery was completed successfully.

• Brand Name: TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16814940
• Report Number: 3005180920-2023-00304
• Device Sequence Number: 12195832
• Product Code: JWH
• UDI-Device Identifier: 07630030827167
• UDI-Public: 07630030827167
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 04/26/2023

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 Expiration Date: 11/01/2025
• Device Model Number: 02.12.T4I3R
• Device Catalogue Number: 02.12.T4I3R
• Device Lot Number: 1907956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2020
• 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