MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-020-11-0235 - truliant ps cem fem ps cem left sz 3.5, (b)(6), 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t, (b)(6), 200-02-29 -three peg patella 29mm, 08004624395, (b)(6) - gps disposable kit, (b)(6), tn190-127-05 - m-class 19/1.27x105, unassigned, z99006 - gps, unassigned, z99011 - truliant tka , unassigned, zbatt-01 , unassigned, zoscl-01, unassigned, zream-01.Description summary: experience report japan h3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that this patient's left total knee arthroplasty (tka) was revised a week post initial operation.After about a week later from a primary surgery, he took x-rays for post operative observation, and found out that the tibial insert was disassociated and moved to anterior side.So he decided to perform revision surgery to exchange tibial insert from ps type 10mm to psc type 9mm because a gap between femoral and tibial components was tight.Also, this patient had one falling down within this period.Patient was last known to be in stable condition following the event.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 10MM
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 21249225
• Report Number: 1038671-2025-00466
• Device Sequence Number: 12776552
• Product Code: JWH
• UDI-Device Identifier: 10885862304353
• UDI-Public: 10885862304353
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-35-3510
• 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: 01/16/2025
• Initial Report FDA Received Date: 01/27/2025
• Date Device Manufactured: 05/05/2022
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female