MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3, 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3017
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision procedure of a right tka, the surgeon was not able to lock the polyethylene insert into place in the appropriate fashion.There was obvious looseness and instability associated with the component.It did not appear that there was obvious damage to the locking mechanism although the surgeon suspected this was likely the case given the near complete wear through of polyethylene posteriorly.Another new polyethylene was brought to the field as well.Again, the surgeon was not able to secure this into place using the standard locking mechanism.Given the inability to secure the poly, plans changed to a complete revision.The surgeon carefully removed the femoral and tibial components.Tibia and femur were reamed.Fully cemented stems for tibia and femur were selected.There was significant bone loss centrally and a cone was prepped for later placement.10 mm posterior augments used laterally.Cement restrictors used in both femur and tibia.The patient was revised to a competitor¿s devices.Patient was last known to be in stable condition following the event.No device returns available.They were sent to the lab and legal department at the hospital.No further information.Revision procedure reported under mdr# 1038671-2023-01537.
Additional Manufacturer Narrative
Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6, h11 mdr section codes updated/corrected: c, d the mating issue may have been the result of residual debris in the mating feature of the tibial tray leading to interference between the mating features of the tray and the tibial insert during assembly.However, this cannot be confirmed because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g3, g4, h1, h6, h11.Mdr section codes updated/corrected: b, c, d, e.The mating issue may have been the result of residual debris in the mating feature of the tibial tray leading to interference between the mating features of the tray and the tibial insert during assembly.However, this cannot be confirmed because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3, 17MM
• 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: 21609460
• Report Number: 1038671-2025-01580
• Device Sequence Number: 9467695
• Product Code: JWH
• UDI-Device Identifier: 10885862307675
• UDI-Public: 10885862307675
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 10/15/2025

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: 02-022-51-3017
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 10/10/2025; 10/10/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male