MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-022-51-3513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and activity.These devices are used for treatment not diagnosis.Concomitant medical products: serial #: (b)(4), catalog #: a10012 - gps implant kit v2, serial #: (b)(4), catalog #: 521-78-36 - threaded pin size 5.1 collarless 2pk, serial #: (b)(4), catalog #: 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t, serial #: (b)(4), catalog #: 02-020-13-0235 - truliant cr cem fem cr cem left sz 3.5, serial #: (b)(4), catalog #: 200-02-32 - three peg patella 32mm, serial #: (b)(4), catalog #: 521-78-31 - threaded pin size 2.6 collarless 2pk, correction/removal number: z-0023-2022.
Event or Problem Description
As reported, the surgeon did a poly exchange on (b)(6) 2022 per patient request due to pain.He stated there was no significant wear found or osteolysis on mri.No issues.Explant not available.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the device was not available for evaluation, and relevant patient information, were not provided.Based on the image and radiograph provided, the tibial insert appears unremarkable for an explanted component.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 3.5, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16196590
• Report Number: 1038671-2023-00044
• Device Sequence Number: 17591061
• Product Code: JWH
• UDI-Device Identifier: 10885862307712
• UDI-Public: 10885862307712
• 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: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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 Expiration Date: 04/17/2026
• Device Model Number: 02-022-51-3513
• Device Catalogue Number: 02-022-51-3513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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 Sex: Female