MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-6009
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint effusion (4849)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: 7021686 02-020-11-0260 - truliant ps cem fem ps cem left sz 6 6095741 02-022-45-6050 - truliant tib fit tray cem sz 6f / 5t 030000 02-029-99-1001 - fluted headless pin 3.0" square head, pk2 025379 02-029-99-1002 - threaded head pin 2.3" square head, pk2 6458787 200-02-41 - three peg patella 41mm.H7: z-0023-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2021.The patient complained of pain and had a recalled poly and was revised on (b)(6) 2024.The insert was replaced.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No reported relevant medical history or comorbidities.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, d4 udi#, h3, h6 type of investigation, investigation findings, investigation conclusions the following sections were corrected: h6 clinical code, problem code, and component code h3: the reason for the revision reported cannot be confirmed from the information provided but may due to the reported pain or inclusion of the polyethylene in the packaging recall.The reason for the clinical symptom of the reported pain cannot be conclusively determined.Prosthesis wear of the tibial insert could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.
Event or Problem Description
Additional information received states that preoperative and postoperative dianoses indicated a failed left total knee arthroplasty secondary to polyethylene wear and synovitis.The patient has had recurrent and persistent effusions with a negative workup for infection.Fluid was sent for gram stain and culture.There was synovitis and granulation tissue, which was debrided.The patella was everted and found to be well fixed without oxidation.The knee was flexed after patellar subluxation.The previous 9mm insert was removed.There were signs of oxidation and polyethylene wear.The femoral and tibial components were checked vigorously and were found to be well fixed.A new 9mm insert was placed and the knee was closed.The patient was awakened and taken to recovery room in stable condition.No further issues or complications were reported.No additional information available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 6 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18592805
• Report Number: 1038671-2024-00132
• Device Sequence Number: 6857890
• Product Code: JWH
• UDI-Device Identifier: 10885862304704
• UDI-Public: 10885862304704
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 02-022-35-6009
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 01/27/2024
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male