MAUDE Adverse Event Report: EXACTECH, INC. LOGIC 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	Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical studies, exactech truliant knee clinical study, that a 67 yo female patient, who had a left knee revision on (b)(6) 2020 following a post traumatic event, ¿subject put knee into valgus while doing yoga¿, then had a spacer implanted on (b)(6) 2020, had a revision of their total knee on (b)(6) 2020.Also noted, there was residual fluid at the wound site, date of onset (b)(6) 2020 which was aspirated and a cortisone injection was administered on (b)(6) 2021.Left knee aspirated also on (b)(6) 2021.The case report does not indicate if this was related to devices or procedure.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 and activity.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 02-010-06-0230 - logic cc femoral size 3, left, 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t, 02-012-61-2000 - logic offset stem ext coupler 2mm, 02-012-61-6000 - logic offset stem ext coupler 6mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: a2, b2, b3, b5, d1, d4 (remove all from initial- suspect product unknown), d6a, d6b (remove erroneous date - in situ), h6 clinical code, impact code, component code, investigation type, findings and conclusion.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 medical intervention cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and activity.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.
Event or Problem Description
It was reported five (5) weeks after a left knee revision, the patient experienced residual fluid at the wound site, as a result, 3 months later the patient underwent left knee aspiration which required a cortisone injection and a follow up aspiration, one month later.The patient outcome was reported as continuing.No additional information is available.

• Brand Name: LOGIC 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: goeff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15253511
• Report Number: 1038671-2022-00939
• Device Sequence Number: 6341189
• 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: 2020
• Device Explanted Year: 2020
• 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): 10/13/2025

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 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: 07/19/2022
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/15/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG