MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 61 y/o female patient had an original bilateral tka procedure with exactech implants on (b)(6) 2019.Patient presented back to surgeon's office with complaints of their tka's and known recalled polyethylene implants.The patient was scheduled for a right knee revision possible poly swap and patella resurfacing on (b)(6) 2023.The patient underwent a tibial polyethylene swap and patella resurfacing.Patient was revised to truliant crc tibial insert sz 3.5, 15mm and optetrak 3 peg patella cemented 32mm.There was no breakage of device or surgical delay/prolongation.The patient left the or stable.Patient was last known to be in stable condition following the event.X-rays and images received, the device is not available for evaluation due to it was discarded at the facility.
Additional Manufacturer Narrative
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, e, 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.Prosthesis wear of the polyethylene components could not be confirmed from the provided information.A contributing factor to the reported wear may have been patient related factors, but this could not be confirmed from the provided information and the devices were not available for evaluation.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 3.5, 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 soza
• MDR Report Key: 18395143
• Report Number: 1038671-2023-03054
• Device Sequence Number: 2691395
• Product Code: JWH
• UDI-Device Identifier: 10885862306425
• UDI-Public: 10885862306425
• 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
• 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): 08/06/2025

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: 07/26/2026
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM
• Device Catalogue Number: 02-022-47-3509
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRULIANT CR POR FEM CR PO; TRULIANT POR TIB TRAY SIZE 3.5F/3.5T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 103 KG