MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532); Implant Pain (4561)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study that the 68 yo male patient experienced a patella tendon rupture.After reporting increased pain in clinic on (b)(6) 2022, the x-rays showed the patella to be high-riding.The surgeon determined the patella tendon had ruptured, and patella-tendon repair surgery was scheduled.The patient was revised on (b)(6) 2022.The outcome was last known as resolved.
Additional Manufacturer Narrative
D10.Concomitants: truliant femoral component ref.No.(b)(4).Tibial tray ref.No.(b)(4).
Event or Problem Description
It was reported via clinical study that the male patient experienced a patella tendon rupture.After reporting increased pain in the clinic, the x-rays showed the patella to be high-riding.The surgeon determined the patella tendon had ruptured, and patella-tendon repair surgery was scheduled.The patient was revised.The outcome was last known as resolved.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b1, b2, b5, d1, d4, g1, h3, h4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the tendon damage reported cannot be conclusively determined but may be related to patient-related conditions, surgical technique, and/or component design.However, this cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, or radiographs 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, 15MM
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 17421510
• Report Number: 1038671-2023-01809
• Device Sequence Number: 15696983
• Product Code: JWH
• UDI-Device Identifier: 10885862307781
• UDI-Public: 10885862307781
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
• Device Catalogue Number: 02-022-51-4015
• 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: 12/11/2025
• Initial Report FDA Received Date: 07/29/2023
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: Black Or African American