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

Model Number	TRULIANT TIB IMP CRC INSERT SZ 4, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 02-020-13-0340, truliant femoral component.No device return anticipated due to clinical study policy.
Event or Problem Description
It was reported via clinical studies, exactech truliant knee clinical study, that a 66 yo male, height: 73 in, who had initial implant on the right knee on (b)(6) 2019, and had a spacer placed on (b)(6) 2020, presented with inflammation to the right knee on (b)(6) 2022.They underwent a revision of the spacer on (b)(6) 2022 and a knee aspiration for culture.Outcome indicates continuing.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 revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Event or Problem Description
It was reported via clinical studies, exactech truliant knee clinical study, that a 66 yo male, height: 73 in, weight: 277 lbs.Who had initial implant on the right knee on (b)(6) 2019, and had a spacer revised on (b)(6) 2020, presented with inflammation to the right knee on (b)(6) 2022.They underwent a revision on (b)(6) 2022 and a knee aspiration for culture.Outcome indicates continuing.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 revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d1, d10, d4 (remove all -suspect product unknown) h4 (remove - unknown), h6: (component code, types of investigation, investigation findings, investigation conclusions), h11.D10: 02-010-06-0340 truliant femoral component, 02-012-65-4015 tibial insert, 02-022-45-4040 tibial tray , 02-012-60-1480 tibial stem extension , 02-012-60-1880 tibial stem extension, 200-07-35 patella component.H11: the cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.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 IMPLANTS
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 15254387
• Report Number: 1038671-2022-00942
• Device Sequence Number: 5807888
• Product Code: JWH
• UDI-Device Identifier: 10885862307750
• UDI-Public: 10885862307750
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 4, 9MM
• Device Catalogue Number: 02-022-51-4009
• 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: Not provided
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 126 KG