MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; SEE H10

Model Number	TRULIANT TIB IMP CRC INSERT SZ 2, 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Female patient, initial right knee implanted on an unknown date, underwent a revision procedure on (b)(6) 2023.The poly from the knee recall was taken out and replaced with a new poly that was not a part of the recall.Patient was last known to be in stable condition following the event.The product was thrown away after surgery.No further information.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer,metal,polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the patient's condition cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: h6 clinical code, component code, types of investigation and investigation conclusions.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 information.The following sections were updated: h11.Information regarding the reason for the revision was not provided.Due to the limited information, this complaint event cannot be further investigated or confirmed, and a definitive cause, in addition to any potential product, patient, and/or user-related contributing factors cannot be definitively determined.There is no indication within the available information that a new or unexpected failure mode or harm/adverse event type has occurred or that the benefit-risk analysis for these products has been altered; therefore, no further risk analysis will be performed.However, this event will be included in complaint trending per (b)(4) complaint trending and actions will be taken as required upon detection of any trend signals.No further action or escalation will be taken at this time concerning this reported event.Should additional relevant information be received concerning this event, the complaint investigation will be re-opened and actions will be taken as appropriate.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16492150
• Report Number: 1038671-2023-00367
• Device Sequence Number: 6367054
• Product Code: JWH
• UDI-Device Identifier: 10885862312525
• UDI-Public: 10885862312525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 04/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 2, 10MM
• Device Catalogue Number: 02-022-51-2010
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 01/09/2026; 04/13/2026
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/22/2023; 01/15/2026; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Female