MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2.5 years post initial left tka, the 59 y/o patient had revision due to pain.There was not much wear reported upon visual examination.There was no issues with poly exchange.The explants are not available for evaluation.
Additional Manufacturer Narrative
Section d10: concomitant products truliant cr por fem cr por left sz 4.5 (cat#: 02-020-14-0245 / serial#: (b)(6).Truliant por tib tray size 4.5f/4.5t (cat#: 02-022-55-4545 / serial#: (b)(6).2 pk, schanz pin, 4mm x 130mm (cat#: 201-78-98 / serial#: (b)(6).Threaded pin size 2.3 collared 2pk (cat#: 521-78-23 / serial#: (b)(6).Threaded pin size 3.0 collarless 2pk (cat#: 521-78-32 / serial#: (b)(6).Threaded pin size 3.0 collarless 2pk (cat#: 521-78-32 / serial#: (b)(6).Threaded pin size 5.1 collarless 2pk (cat#: 521-78-36 / serial#: (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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: a, b, c, d, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17362347
• Report Number: 1038671-2023-01720
• Device Sequence Number: 14955337
• Product Code: JWH
• UDI-Device Identifier: 10885862312679
• UDI-Public: 10885862312679
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 10/29/2025

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 Model Number: TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM
• Device Catalogue Number: 02-022-51-4510
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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: 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
• Patient Age: 59 YR
• Patient Sex: Unknown