MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CR INS STD SZ 2.5, 9 MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.3 years post initial right tka, the 47 y/o female patient presented back to surgeon's office with right knee instability and confirmed recalled polyethylene.The patient was scheduled for a right tka revision poly swap and patella resurfacing with an implant.The patient had a revision right knee procedure where the original poly implant was removed, and a new thicker 13mm crc anterior stabilize insert was chosen and implanted.The patella was also resurfaced with a round 32mm patella implant.The patient left the or stable.There was no breakage of the device.Patient was last known to be in stable condition following the event x-rays received.The devices are not available for evaluation due to the implant goes to the lab and then legal and is retained by the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products truliant cr por fem cr por right sz 2.5 (cat# 02-020-14-0325 / serial#: (b)(4)); truliant por tib tray size 2.5f/2.5t (cat# 02-022-55-2525 / serial#: (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: investigation results - the optetrak device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s knee instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.Corrected h6 health effect - clinical code to reflect the indicated failure mode.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, h6: health effect - clinical code, medical device problem code, component code.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 CR INS STD SZ 2.5, 9 MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16696763
• Report Number: 1038671-2023-00600
• Device Sequence Number: 17560464
• Product Code: JWH
• UDI-Device Identifier: 10885862306326
• UDI-Public: 10885862306326
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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 Expiration Date: 01/04/2026
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 2.5, 9 MM
• Device Catalogue Number: 02-022-47-2509
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 10/14/2025
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 12/21/2023; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2018
• 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
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 89 KG