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

Model Number	TRULIANT TIB IMP CRC INSERT SZ 2, 15MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, exactech truliant knee clinical study, that a 78 yo female, height: 156cm, weight: 88 kgs, who had an initial right knee implanted on (b)(6) 2021 for the primary indication of osteoarthritis, indicated they had infection, increased pain and swelling in right knee reported at 8-16-22 visit in which labs were done showing elevated levels for possible infection.Revision was done on (b)(6) 2022 with competitors¿ devices.The study indicates the outcome as resolved, functional restoration type as full.Related to device: definitely not, related to procedure: possibly.
Additional Manufacturer Narrative
No device return anticipated due to clinical study policies.Concomitant medical products: 02-020-13-0320 - truliant cr cem fem cr cem right sz 2 6978838, 02-022-45-2030 - truliant tib fit tray cem sz 2f / 3t 6758270.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: 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 for infection cannot be conclusively determined; however, it is most likely related to patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b4, d1, d4 (remove expiration date), g4, h4 (remove manufactured date), h6: clinical code, component code, type of investigation, investigation findings, 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 this female patient who had an initial right knee implanted for the primary indication of osteoarthritis, indicated they had infection, increased pain and swelling in right knee reported at visit in which labs were done showing elevated levels for possible infection.Revision was done with competitors¿ devices.The study indicates the outcome as resolved, functional restoration type as full.

• Brand Name: UNKNOWN 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: geoff gannon ; 3523771140
• MDR Report Key: 15480667
• Report Number: 1038671-2022-01156
• Device Sequence Number: 20570914
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2026

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 Model Number: TRULIANT TIB IMP CRC INSERT SZ 2, 15MM
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 02/10/2026
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/20/2022; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: Black Or African American