MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-2021
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-06-0220 - tru cc femoral size 2 left: (b)(6), 02-012-60-1412 - tru stem ext 14mm x 120mm: (b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm: (b)(6), 02-022-45-2530 - truliant tray, cem sz 2.5f/3t: (b)(6), 02-024-35-2515 - activite trlnt ps insrt size 2.5, 15mm: (b)(6), 201-78-89 - 3" drill bit, mod.Hex 2 pack: (b)(6), 204-70-00 - tibial stem ext.Screw: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that during a revision procedure on a left tka, a poly-to-tibial tray mismatch was left uncorrected: a size 2 cc poly with a 2.5f/3t tibial tray.During the revision, a 2.5f/3t tibial tray was implanted with a 14mm o.D.X 25mm length stem, with the plan for a left 2.5 ps femoral component.After the tibia was cemented, the femoral component was implanted with cement.After holding the femoral component to the femur for roughly 10 minutes to ensure the cement had set, he let go and realized the femoral component was not staying.The surgeon decided to go to a cc femur with a stem.A size 2 cc femur with a 17mm cc tibial insert.They cemented a left size 2 cc femur with a 14 mm o.D.X 120mm length stem.They then inserted the 17mm cc tibial insert and realized a larger insert was needed, thus removing and inserting a 21mm cc tibial insert with the locking screw going through the tibial insert, the tibial tray, and the stem.The final construct implanted in the patient was a left size 2 cc femoral component with a 14 mm o.D.X 120mm length stem on the femoral side.On the tibial size, there is size 2 21mm cc tibial insert with a size 2.5f/3t tibial tray, and a 14mm o.D.X 25mm length stem that is all connected with the long screw that comes with the cc tibial insert.This mistake was noticed, and the surgeon was notified shortly after.No revision to correct the poly to tibial construct implanted has occurred.The existing tibial insert was observed to be securely fastened to the tibial tray with the long locking screw provided with the tibial insert.The customer is currently working on getting a tibial insert that will fit a 2.5f/3t tibial tray, to allow the surgeon the option to do a poly swap if he decides to do so.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.No further information.This is 1 of 2 events for this patient.

• Brand Name: TRULIANT CC
• 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: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24748518
• Report Number: 1038671-2026-00362
• Device Sequence Number: 9091869
• Product Code: JWH
• UDI-Device Identifier: 10885862613356
• UDI-Public: 10885862613356
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/31/2026

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: 02-012-65-2021
• 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: 03/11/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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 Age: 72 YR
• Patient Sex: Female