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

Model Number	TRULIANT TIB IMP PS INSERT SZ 4 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthrofibrosis (4885)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic cc femoral size 4, left (cat# 02-010-06-0240).Truliant tib fit tray cem sz 4f / 4t (cat# 02-022-45-4040).Tru fluted stm ext 16mm x 80mm blast (cat# 02-012-64-1680).Tibial stem ext.Screw (cat# 204-70-00).Tru fluted stm ext 18mm x 80mm blast (cat# 02-012-64-1880).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech knee replacement study, approximately three months post initial tka, the 58 y/o male patient complains of stiffness in both knees.Patient had x-rays and zilretta injections.Patient was ordered evaluation and therapy and the event was resolved.Per clinical study case report form indicates this event is unlikely related to devices and possibly related to procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported by the exactech knee replacement study, approximately three months post initial tka, the 58 y/o obese male patient complains of stiffness in both knees due to arthrofibrosis.Patient had x-rays and triamcinolone acetonide extended-release injectable suspension injections.Patient was ordered evaluation and therapy and the event was resolved.Per clinical study case report form indicates this event is unlikely related to devices and possibly related to procedure.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.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 initial report-suspect device unknown), d8, g4 (remove 501k from initial report-unknown), h6: clinical codes, impact codes, component code, types of investigation and investigation conclusion code.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: 15191784
• Report Number: 1038671-2022-00902
• Device Sequence Number: 12170661
• Product Code: JWH
• UDI-Device Identifier: 10885862304452
• UDI-Public: 10885862304452
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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 Model Number: TRULIANT TIB IMP PS INSERT SZ 4 11MM
• Device Catalogue Number: 02-022-35-4011
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 12/04/2025
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/22/2022; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 122 KG