MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PS INSERT SZ 4 9MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech truliant knee clinical study, approximately one year post initial left tka, the 67 y/o female presented with redness, patient had swelling left knee.X-ray showed anterior soft tissue swelling, narrow zones of periprosthetic lucency.Patient was admitted and rx'd daptomycin.The surgeon performed ltk revision for incision and drainage with poly exchange.Patient was discharged home seven days later with rx'd pain medication and asa x4 weeks and antibiotic x6 weeks.Per clinical report, the reported event is not related to the device but definitely related to the procedure.
Additional Manufacturer Narrative
The reason for the reported surgical intervention due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 9MM
• 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 ; gainesville 32653
• MDR Report Key: 19165588
• Report Number: 1038671-2024-00951
• Device Sequence Number: 15284820
• Product Code: JWH
• UDI-Device Identifier: 10885862304438
• UDI-Public: 10885862304438
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 9MM
• Device Catalogue Number: 02-022-35-4009
• Device Lot Number: UNKNOWN
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2022
• 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: ADVANCED PATELLA 35MM 3 PEG IMPLANT.; TRULIANT PS CEM FEM PS CEM LEFT SZ 4.; TRULIANT TRAY, CEM SZ 4F/3.5T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White