MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP PS INSERT SZ 5 10MM
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5383670, 200-02-32, three peg patella 32mm; 5788503, 02-022-45-5040, truliant tib fit tray cem sz 5f / 4t; 6374371, 02-020-11-0250, truliant ps cem fem ps cem left sz 5; 6424600, 201-78-15, holding pin mini sharp point 4 pk.
Event or Problem Description
It was reported a male patient, initial tka, left knee, implanted on (b)(6) 2020, was revised on (b)(6) 2022, approximately 2 years, 5 months post the initial procedure.The patient had bilateral knee replacements with the exactech system, on different dates.His right side has done very well but his left had pain and mechanical clicking for over a year.The patient became concerned after receiving the recall notice and saw his surgeon for evaluation.He was not debilitated with the knee symptoms but found them very annoying.Poly exchange for recall was performed.The patient was doing well after surgery.The explanted poly has been returned.
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 pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient underlying conditions 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.It is noted that "clicking" can indicate positional changes in the implant that could lead to premature failure.
Event or Problem Description
No additional information has been provided, after multiple attempts.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision reported was likely the result of disassembly of the tibial insert from the tibial tray, which led to wear of the backside of the insert.Possible contributing factors to tibial insert disassembly include patient-related conditions, a post-traumatic event, incomplete seating of the tibial insert at the time of implantation, or any combination of these possibilities.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
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.The revision reported was likely the result of disassembly of the tibial insert from the tibial tray, which led to wear of the backside of the insert.Possible contributing factors to tibial insert disassembly include patient-related conditions, a post-traumatic event, incomplete seating of the tibial insert at the time of implantation, or any combination of these possibilities.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 10MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16052481
• Report Number: 1038671-2022-01628
• Device Sequence Number: 6257966
• Product Code: JWH
• UDI-Device Identifier: 10885862304629
• UDI-Public: 10885862304629
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/11/2025

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 Model Number: TRULIANT TIB IMP PS INSERT SZ 5 10MM
• Device Catalogue Number: 02-022-35-5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 12/28/2022; 11/10/2025; 11/10/2025
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/24/2023; 11/11/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• 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 Sex: Male