MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 6 9MM; SEE H10

Catalog Number	02-022-35-6009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient has filed a short-form complaint in a coordinated action in (b)(6) 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.D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Multiple devices are listed, the patient had concurrent bilateral knee arthroplasty (b)(6), 02-022-45-6050 - truliant tib fit tray cem sz 6f / 5t.(b)(6), 02-020-11-0360 - truliant ps cem fem ps cem right sz 6.(b)(6), 02-022-45-6050 - truliant tib fit tray cem sz 6f / 5t.(b)(6), 200-07-35 - advanced patella 35mm 3 peg implant.(b)(6), 200-07-35 - advanced patella 35mm 3 peg implant.(b)(6), 02-022-35-6009 - truliant tib imp ps insert sz 6 9mm.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that this patient had an initial right total knee arthroplasty on (b)(6) 2019.There is no reported revision at this time.There is no other patient demographic or medical history available.No additional information is available.
Additional Manufacturer Narrative
H3: investigation results - as documented, there appears to be an allegation of prosthesis wear against the devices implanted in the right knee.However, the devices remain implanted, prosthesis wear cannot be confirmed from the information provided, and the allegation may be due inclusion of the implanted polyethylene in the packaging recall.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, e4: removed erroneous entry, g1, g2, h6: clinical code, impact code, component code, type of investigation.As documented, there appears to be an allegation of prosthesis wear against the devices implanted in the right knee.However, the devices remain implanted, prosthesis wear cannot be confirmed from the information provided, and the allegation may be due inclusion of the implanted polyethylene in the packaging recall.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 6 9MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17912830
• Report Number: 1038671-2023-02501
• Device Sequence Number: 6653389
• Product Code: JWH
• UDI-Device Identifier: 10885862304704
• UDI-Public: 10885862304704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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 Expiration Date: 05/18/2026
• Device Catalogue Number: 02-022-35-6009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 02/06/2026
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/04/2024; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• 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
• 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 Sex: Unknown