MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-47-2011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech truliant knee clinical study, the 69 year old female patient had an initial right tka on (b)(6) 2017.The patient presented on (b)(6) 2023 with tricompartmental degenerative changes with lateral joint space narrowing, sclerosing and osteophyte formation.The case report form indicates that this event is possibly related to device and definitely not related to procedure.Outcome is continuing.Patient was having discomfort; pain was related more to the joint capsule and not the hardware.Patient declined elective revision surgery.Topical anesthetic cream was prescribed.
Additional Manufacturer Narrative
(d10) concomitant device(s): (b)(6): 02-020-13-0320 - truliant cr cem fem cr cem right sz 2.(b)(6): 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t.(b)(6): 200-07-32 - advanced patella 32mm 3 peg implant.
Additional Manufacturer Narrative
The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, or radiographs were not provided.D4: corrected h6: corrected health effect, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 2, 11MM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18279511
• Report Number: 1038671-2023-02923
• Device Sequence Number: 6761921
• Product Code: JWH
• UDI-Device Identifier: 10885862306289
• UDI-Public: 10885862306289
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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 Expiration Date: 12/29/2024
• Device Catalogue Number: 02-022-47-2011
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2017
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: Black Or African American