MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3012
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Implant Pain (4561)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 6 y/o male patient's right knee was revised approximately 8 months post op initial surgery.The patient returned to surgeons office with complaints of popping, clicking, pain, and dissatisfaction with their tka.Upon examination the patient presented with slight instability.The patient was scheduled for a revision tka poly swap with synovectomy.The revision was performed on (b)(6) 2024 and the patient underwent a synovectomy and tibial poly insert swap.Patient was last known to be in stable condition following the event.Devices not returning, discarded at the facility.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s):(b)(6) 02-022-45-3025 - truliant tray, cem sz 3f/2.5t.(b)(6) 200-02-35 - three peg patella 35mm.(b)(6) 02-020-11-0330 - truliant ps cem fem ps cem right sz 3.
Additional Manufacturer Narrative
H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 12MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177858
• Report Number: 1038671-2024-00969
• Device Sequence Number: 7231866
• Product Code: JWH
• UDI-Device Identifier: 10885862304285
• UDI-Public: 10885862304285
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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 Catalogue Number: 02-022-35-3012
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male