MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT POR TIB TRAY SIZE 3.5F/2.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-55-3525
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.As reported, a patient had a left total knee arthroplasty.Subsequently, one (1) year, seven (7) months later, the patient underwent a left knee revision due to inadequate osteointegration of the porous components.As a result, the patient was revised to cemented components.The patient was last known to be in stable condition following the event.No additional medical or clinical information was provided.No additional information is available.

• Brand Name: TRULIANT POR TIB TRAY SIZE 3.5F/2.5T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: julia goldberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25761438
• Report Number: 1038671-2026-00867
• Device Sequence Number: 10537406
• Product Code: JWH
• UDI-Device Identifier: 10885862317155
• UDI-Public: 10885862317155
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 09/15/2025
• Device Catalogue Number: 02-022-55-3525
• 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: 08/30/2022
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 09/16/2020
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female