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

Model Number	TRULIANT TIB IMP PS INSERT SZ 2 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthrofibrosis (4885); Crepitus (4893)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the truliant knee clinical study, approximately one year post initial left side tka, this 53 y/o female patient experienced arthrofibrosis.Patient complaints of continuing post-operative left knee pain.Surgeon discussed radiographic findings with the patient as well as treatment options.Surgeon believes patient has some scar tissue on the medial aspect with some crepitus and point tenderness.She has failed conservative treatment.She is scheduled with surgeon as she may benefit from arthroscopy.The event was resolved with patient having knee arthroscopy plica excisions and synovectomy (b)(6) 2018.
Additional Manufacturer Narrative
Concomitant medical products: truliant ps cem fem ps cem left sz 2 (cat#: 02-020-11-0220 / serial#: (b)(4)).Truliant tib fit tray cem sz 2f / 2t (cat#: 02-022-45-2020 / serial#: (b)(4)).Three peg patella 26mm (cat#: 200-02-26 / serial#: (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) as reported by the truliant knee clinical study, approximately one year post initial left side tka, this 53 y/o female patient experienced arthrofibrosis.Patient complaints of continuing post-operative left knee pain.Surgeon discussed radiographic findings with the patient as well as treatment options.Surgeon believes patient has some scar tissue on the medial aspect with some crepitus and point tenderness.She has failed conservative treatment.She is scheduled with surgeon as she may benefit from arthroscopy.The event was resolved with patient having knee arthroscopy plica excisions and synovectomy on (b)(6) 2018.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, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from the initial report-suspect device unknown), d8, e4 (remove erroneous entry from initial report), g4 (remove 501k from the initial report-unknown), h4 (remove erroneous entry from initial report), h6: health effect clinical codes, health effect- impact code, component code, type of investigation and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: UNKNOWN TRULIANT KNEE COMPONENT
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16253779
• Report Number: 1038671-2023-00058
• Device Sequence Number: 17480413
• Product Code: JWH
• UDI-Device Identifier: 10885862304070
• UDI-Public: 10885862304070
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2 10MM
• Device Catalogue Number: 02-022-35-2010
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 02/28/2026
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/21/2023; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White