MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 3, 13MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Joint effusion (4849)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic cc femoral size 3, right (cat# 02-010-06-0330).Lgc tibial fit tray cem sz 3f / 2t (cat# 02-012-45-3020).Logic stem ext 20mm x 80mm (cat# 02-012-60-2080).Advanced patella 32mm 3 peg implant (cat# 200-07-32).Metaphyseal tibial cone, ml32mm (cat# 02-012-66-2000).Tibial stem ext.Screw (cat# 204-70-00).Cc distal fem augment sz 3, 10mm (cat# 208-06-03).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech truliant knee clinical study, approximately one year post initial tka, the 62 y/o female patient experienced inflammation with pain and stiffness, moderate knee effusion.Patient had a joint aspiration on (b)(6) 2020 and the event was resolved.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported by the exactech truliant knee clinical study, approximately one year post initial tka for osteoarthritis, the 62 y/o underweight female patient experienced inflammation with pain and stiffness, and moderate knee effusion.Patient had a joint aspiration on (b)(6) 2020 and the event was resolved.The this event report was received through clinical data collection activities.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b3 (correct initial report to 19-mar-2020), d1, d4(remove all from initial report-suspect device unknown), d8, g4 (remove 501k from initial report-unknown), h6: clinical codes, impact code, component code, type of investigation and investigation conclusions) if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15191868
• Report Number: 1038671-2022-00903
• Device Sequence Number: 5566861
• Product Code: JWH
• UDI-Device Identifier: 10885862305114
• UDI-Public: 10885862305114
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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 PSC INSERT SZ 3, 13MM
• Device Catalogue Number: 02-022-44-3013
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 01/14/2026
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/23/2022; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 52 KG