MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-022-35-2009
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4) category #: 200-02-35 - three peg patella 35mm, serial #: (b)(4) category #: 521-78-32 - threaded pin size 3.0 collarless 2pk, serial #: (b)(4) category #: 201-78-15 - holding pin mini sharp point 4 pk, serial #: (b)(4) category #: 521-78-23 - threaded pin size 2.3 collared 2pk, serial #: (b)(4) category #: 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t, serial #: (b)(4) category #: 02-020-11-0220 - truliant ps cem fem ps cem left sz 2, serial #: (b)(4) category #: 203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7.
Event or Problem Description
It was reported via clinical study, that the 50 yo female patient was experiencing instability total knee arthroplasty.The date of adverse event onset is (b)(6) 2020.The patient was treated with conservative measures over the last year consisting of activity modification, assistive device use, nsaids, pt, and weight loss attempts were unsuccessful, and gross global extension and flexion instability were observed.Physician endorsed synovectomy and liner exchange.The patient was revised on (b)(6) 2020.The patient¿s outcome was last known as resolved on (b)(6) 2020.
Additional Manufacturer Narrative
Section h10: (h3) 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.The patient has lupus which is a cause of ligament and joint maladies.These devices are used for treatment not diagnosis.Section h11: *the following sections have corrected information: (b5) describe event or problem: it was reported via clinical study, that the 50 yo female patient was experiencing instability total knee arthroplasty.The date of adverse event onset is 02/20/2020.The patient was treated with conservative measures over the last year consisting of activity modification, assistive device use, nsaids, pt, and weight loss attempts were unsuccessful, and gross global extension and flexion instability were observed.Physician endorsed synovectomy and liner exchange.The patient was revised on (b)(6) 2020.The patient¿s outcome was last known as resolved on (b)(6) 2020.The case report form indicates this event is unlikely not related to device and unlikely related to procedure.(d1) brand name: truliant tib imp ps insert sz 2 9mm.
Event or Problem Description
It was reported via clinical study, that the 50 yo female patient was experiencing instability total knee arthroplasty.The date of adverse event onset is 02/20/2020.The patient was treated with conservative measures over the last year consisting of activity modification, assistive device use, nsaids, pt, and weight loss attempts were unsuccessful, and gross global extension and flexion instability were observed.Physician endorsed synovectomy and liner exchange.The patient was revised on (b)(6) 2020.The patient¿s outcome was last known as resolved on (b)(6) 2020.The case report form indicates this event is unlikely not related to device and unlikely related to procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2022-01561.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2 9MM
• 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: kate jacobson
• MDR Report Key: 16678638
• Report Number: 1038671-2023-00581
• Device Sequence Number: 7387610
• Product Code: JWH
• UDI-Device Identifier: 10885862304063
• UDI-Public: 10885862304063
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 09/07/2025
• Device Catalogue Number: 02-022-35-2009
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 09/21/2023; 10/21/2025
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 10/11/2023; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White