MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Arthrofibrosis (4885)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had right total knee replacement.They underwent right knee revision surgery, approximately 1 year post primary procedure.Revision op report noted the synovial tissue looked healthy, and there were no signs of mucus or purulence or significant synovitis; however, there was significant scar tissue of the synovial tissue.The patellar button was well-fixed in a good position.There were no damage or signs of delamination on gross inspection of the tibial insert.The components were well fixed and in appropriate alignment.The surgeon noted that the patient's bone quality was quite poor.There were no intraoperative fractures.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25857360
• Report Number: 1038671-2026-00908
• Device Sequence Number: 5266266
• Product Code: JWH
• UDI-Device Identifier: 10885862304520
• UDI-Public: 10885862304520
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• 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,Followup
• Report Date (Section B): 07/17/2026

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 Catalogue Number: 02-022-35-4509
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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
• Patient Age: 53 YR
• Patient Sex: Female