MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-4012
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a database review for a related case, it was found that a patient had underwent a revision procedure of their right knee which was initially implanted in (b)(6) 2019.The tibial psc insert was revised in (b)(6) 2021 approximately 1 year 10 months post the initial procedure.Reason for the revision is unknown.The tibial implant was revised to same device.No further information is available.This is 1 of 2 events.
Additional Manufacturer Narrative
D10: concomitants: 6290137 02-020-11-0340 - truliant ps cem fem ps cem right sz 4.6310351 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t.6086634 200-02-38 - three peg patella 38mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
D1: corrected.H6: corrected component, and investigation clinical codes.H10: corrected.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4, 12MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21608391
• Report Number: 1038671-2025-01577
• Device Sequence Number: 13080229
• Product Code: JWH
• UDI-Device Identifier: 10885862305299
• UDI-Public: 10885862305299
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 02-022-44-4012
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 01/14/2019
• 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: Required Intervention
• Patient Sex: Unknown