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

Model Number	02-022-35-2009
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2017.The patient has failed conservative management to include nsaids, physical therapy, steroid injection, assistive devices and life style modifications.Due to worsening pain in left replaced knee, a positive bone scan around femur, deteriorating range of motion, progressive deformity, and significant interference with function, the only option for pain control and functional restoration is a total knee replacement revision.The patient had a complete femoral revision with polyethylene exchange and retention of patellar component on (b)(6) 2020.The case report form indicates this event is unlikely related to devices or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-020-11-0220 - truliant ps cem fem ps cem left sz 2, (b)(4), 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t, (b)(4), 200-02-32 - three peg patella 32mm (b)(4), 201-78-15 - holding pin mini sharp point 4 pk (b)(4), 203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7 (b)(4).Recall number: z-0023-2022.
Additional Manufacturer Narrative
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 for 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: b1, b2, b3, d1, d4 (remove all from initial report-suspect device unknown), d8, f6 and f9 (remove erroneous dates from initial report), g4 (remove 501k from initial report-unknown), h4 (remove manufacture date from initial report-unknown), h6 clinical code, device problem code, component code, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15538623
• Report Number: 1038671-2022-01236
• Device Sequence Number: 15224747
• Product Code: JWH
• UDI-Device Identifier: 10885862304063
• UDI-Public: 10885862304063
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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: 04/19/2025
• Device Model Number: 02-022-35-2009
• Device Catalogue Number: 02-022-35-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 01/22/2026
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/08/2022; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White