MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4012
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Arthralgia (2355); Ambulation or Postural Difficulties (2544); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitants: unkown truliant insert from 2020.5603049, 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t 5611018, 200-07-35 - advanced patella 35mm 3 peg implant 5699869, 201-78-15 - holding pin mini sharp point 4 pk pending investigation.
Event or Problem Description
It was reported that a patient had a right knee revision, reason not provided.Initial implant (b)(6) 2018 and a total knee revision on (b)(6) 2023.Total revision approximately 4 years 10 months after initial implant.For all other implants and the patient was revised to exactech devices.Reported event is not related to breakage of device and did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.There is no other patient/medical information provided.There is no information about the revision surgical procedure provided.There is no other information provided.
Additional Manufacturer Narrative
Additional manufacturer narrative- h6.Health effect - clinical code & medical device problem code.Correction- d4 tibial insert information is unknown, d6a for tibial insert date.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g4, h4, h6.Mdr section codes updated/corrected: b, c, d, e.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 relevant clinical information was not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18518328
• Report Number: 1038671-2024-00092
• Device Sequence Number: 7698704
• Product Code: JWH
• UDI-Device Identifier: 10885862304469
• UDI-Public: 10885862304469
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: 04/06/2026
• Device Catalogue Number: 02-022-35-4012
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 06/04/2024; 10/15/2025
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 06/04/2024; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 124 KG