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

Model Number	02-022-47-2509
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); Arthrofibrosis (4885)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-012-60-1440 - logic stem ext 14mm x 40mm 6512163, 02-020-13-0235 - truliant cr cem fem cr cem left sz 3.5 6214474, 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t 6449532, 200-02-38 - three peg patella 38mm 6529909, 204-70-00 - tibial stem ext.Screw 6605741, concomitant medical products: z-0023-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2020.The patient presented with left knee stiffness, decreased rom, and pain.Action taken: medication.This event report was received through clinical data collection activities.
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 stiffness, decreased range of motion and pain cannot be conclusively determined, however, it is most likely related to the patient¿s underlying condition of arthrofibrosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b3, d1, d4 (remove all from initial report-suspect device unknown), d8, g4 (remove 501k from initial report-unknown), h1 (correcting initial and follow up -1 reports to serious injury), h4 (remove manufacture date from initial report-unknown), h6 clinical codes, impact codes, device problem code, component code, type of investigation, 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: 15569371
• Report Number: 1038671-2022-01271
• Device Sequence Number: 20479177
• Product Code: JWH
• UDI-Device Identifier: 10885862306326
• UDI-Public: 10885862306326
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

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: 01/17/2026
• Device Model Number: 02-022-47-2509
• Device Catalogue Number: 02-022-47-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 01/21/2026
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/08/2022; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White