MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-2009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	02/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.D10: 6087194 02-020-11-0320 - truliant ps cem fem ps cem right sz 2; 5737872 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t; ab3521 1400-ag - cemex gento low viscosity 40g kit.
Event or Problem Description
As reported, approximately 4 years post the initial right total knee arthroplasty, the patient was revised due to a swollen, painful knee.The poly was revised to a new poly.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The reason for the joint effusion/swelling reported cannot be conclusively determined and the reported event could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.H6: corrected health effect and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21442759
• Report Number: 1038671-2025-01146
• Device Sequence Number: 7939571
• Product Code: JWH
• UDI-Device Identifier: 10885862304063
• UDI-Public: 10885862304063
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 08/08/2025

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 Catalogue Number: 02-022-35-2009
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 02/23/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 05/03/2019
• 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: 57 YR
• Patient Sex: Female