MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	TRULIANT TIB IMP CRC INSERT SZ 4.5, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 65 yo male patient, initial left knee implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The tibial insert was exchanged for a new one of the same size during a washout procedure for suspected infection.There was no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays or photos provided, unable to obtain.No device returning due to hospital policy.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: a494252, 02-020-13-0245 - truliant cr cem fem cr cem left sz 4.5.A325422, 02-022-45-4540 - truliant tray, cem sz 4.5f/4t.A479213, 02-029-90-4300 - sterile packed short headed pin.A349477, 200-07-35 - advanced patella 35mm 3 peg implant.A468382, 201-78-81 - 3" trocar, mod.Hex 2pk.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported revision due to infection in cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4.5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17388140
• Report Number: 1038671-2023-01758
• Device Sequence Number: 12337912
• Product Code: JWH
• UDI-Device Identifier: 10885862307811
• UDI-Public: 10885862307811
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: TRULIANT TIB IMP CRC INSERT SZ 4.5, 9MM
• Device Catalogue Number: 02-022-51-4509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 02/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male