MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 2.5, 13 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP CR INS STD SZ 2.5, 13 MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to clinical study policy.Concomitant medical products: 02-020-13-0225 - truliant cr cem fem cr cem left sz 2.5, (b)(4).02-022-45-2535 - truliant tib fit tray cem sz 2.5f / 3.5t, (b)(4).201-78-81 - 3" trocar, mod.Hex 2pk, (b)(4).Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely patient-related conditions.
Event or Problem Description
It was reported via the exactech truliant knee clinical study, that a 74 yo obese female patient, who was initially implanted with a left knee on (b)(6) 2017, for the primary indication of osteoarthritis, underwent a revision procedure on (b)(6) 2020, approximately 4 years 10 months post the initial implant procedure.Date of onset, (b)(6) 2020.The study indicates inflammation, definitely not related to devices or procedure.The tibial insert was revised, and labs sent from left knee fluid.Outcome indicates resolved on (b)(6) 2020.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, b2, b5, d1, g1, h6: clinical code, medical device code, component code, types of investigation, investigation findings, and investigation conclusions.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 that a female patient, who was initially implanted with a left knee for the primary indication of osteoarthritis, underwent a revision procedure, approximately 4 years 10 months post the initial implant procedure.The study indicates inflammation, definitely not related to devices or procedure.The tibial insert was revised, and labs sent from left knee fluid.Outcome indicates resolved.No additional information.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 2.5, 13 MM
• 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: geoff gannon ; 3523771140
• MDR Report Key: 15769830
• Report Number: 1038671-2022-01438
• Device Sequence Number: 5145141
• Product Code: JWH
• UDI-Device Identifier: 10885862306340
• UDI-Public: 10885862306340
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2025
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 2.5, 13 MM
• Device Catalogue Number: 02-022-47-2513
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 02/26/2026
• Date Device Manufactured: 02/07/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: Black Or African American