MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Insufficient Information (4580); Joint effusion (4849)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee revision on (b)(6) 2020.This device has not been explanted.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The patient has filed a complaint in a coordinated action in (b)(6) county with master case no.(b)(4).The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.
Additional Manufacturer Narrative
D10.Concomitants: optetrak femoral aug block & screw (208-05-04, 4858356) optetrak logic fit tibial tray (02-012-45-4030, 5282350) optetrak logic stem extension femoral and tibial (02-012-60-1440, 6529292) optetrak tibial stem extension screw (204-70-00, 6580212) optetrak 3 peg advanced patella (200-07-29, 6015839) optetrak logic femoral component (02-010-06-0240, 5553653) optetrak logic stem extension femoral and tibial (02-012-60-1440, 5835494) optetrak femoral aug block & screw (208-05-04, 4858366) optetrak logic femoral augment & screw posterior, cemented (02-010-06-0541, 5930806) optetrak logic femoral augment & screw posterior, cemented (02-010-06-0541, 5702064) initial submission: all fields in section f should be blank, this is a manufacturer's report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
It is documented via legal documentation approximately 46 months after a revision left knee replacement surgery, the patient underwent a second revision left knee replacement surgery.The patient experienced left anterior knee pain and recurrent effusions.A revision operative report was provided pre-operative work up for infection was noted to be negative.X-rays showed loosening of patellar component with osteolysis.Intraoperatively the tibial insert, upon removal, was noted to have signs of oxidative changes.The femoral and tibial components were noted to be well fixed.The patellar component was significantly loose.The surgeon observed and noted a very thin patella with concavity.It was elected to proceed with bone grafting and not resurfacing.There were no medical or surgical interventions reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6b, h6.Mdr section codes updated/corrected: b, c.The reason for the revision reported cannot be confirmed from the information provided but may be the result of patellar loosening or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the patella implant to the patellar bone, may have led to loosening at the cement-bone interface; however, this cannot 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.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 PS INSERT SZ 4 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17783207
• Report Number: 1038671-2023-02332
• Device Sequence Number: 20206737
• Product Code: JWH
• UDI-Device Identifier: 10885862304476
• UDI-Public: 10885862304476
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2025

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 Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-022-35-4013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 06/22/2024; 08/12/2025
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/01/2023; 04/01/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Weight: 76 KG