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

Model Number	TRULIANT TIB IMP PSC INSERT SZ 2, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ankylosis (4527); Implant Pain (4561)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device return not anticipated.It remains implanted.Concomitants: 02-020-11-0220 - truliant ps cem fem ps cem left sz 2.02-022-45-2010 - truliant tib fit tray cem sz 2f / 1t.200-07-29 - advanced patella 29m 3 peg implant.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via clinical studies, exactech truliant knee clinical study, that a 80 yo female with a primary diagnosis of osteoarthritis, who had initial left knee replacement on (b)(6) 2019, was seen for a stiff and painful knee, (ankylosis) approximately 2 months post the initial procedure and underwent a closed manipulation.The information indicated the outcome as resolved (b)(6) 2019.Study notes do not indicate if this event is related to the devices or the procedure.
Additional Manufacturer Narrative
H7: z-0023-2022.
Additional Manufacturer Narrative
H2: 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from initial report-suspect device unknown), e2, e3, g4 (remove 501k from initial report-unknown) h6: clinical codes, impact code, component code, types of investigation, investigation findings and investigation conclusion.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 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: 15251260
• Report Number: 1038671-2022-00937
• Device Sequence Number: 6612566
• Product Code: JWH
• UDI-Device Identifier: 10885862304896
• UDI-Public: 10885862304896
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2025

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 Expiration Date: 08/28/2025
• Device Model Number: TRULIANT TIB IMP PSC INSERT SZ 2, 9MM
• Device Catalogue Number: 02-022-44-2009
• 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: 08/22/2022; 08/22/2022; 12/03/2025
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/28/2022; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 44 KG