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

Model Number	TRULIANT TIB IMP PSC INSERT SZ 3, 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant medical products: lgc tibial fit tray cem sz 3f / 2t (cat# 02-012-45-3020).Advanced patella 29m 3 peg implant (cat# 200-07-29).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 1.5 years post initial right tka, the 54 y/o female patient's pain is constant, aching, throbbing and sharp if it pops.The event was resolved with medication.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 1.5 years post initial right tka for post-traumatic osteoarthritis, the 54 y/o obese female patient's pain is constant, aching, throbbing and sharp if it pops.The event was resolved with medication.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: b3, d1, d4 (remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown) d8, d10, h6: impact code, component code, type of investigation and investigation conclusion.D10: lgc tibial fit tray cem sz 3f / 2t (02-012-45-3020).Advanced patella 29m 3 peg implant (200-07-29).Truliant tib imp psc insert sz 3, 10mm (02-022-44-3010).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT/OPTETRAK KNEE COMPONENTS
• 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: 15188429
• Report Number: 1038671-2022-00901
• Device Sequence Number: 17731285
• Product Code: JWH
• UDI-Device Identifier: 10885862305084
• UDI-Public: 10885862305084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• 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): 12/03/2025

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, 10MM
• Device Catalogue Number: 02-022-44-3010
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 11/28/2025
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/23/2022; 12/03/2025
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 88 KG