MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-020-11-0320
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Discomfort (2330); Joint Laxity (4526); Implant Pain (4561); Crepitus (4893)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the pain 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 [overweight, previous knee procedures], unique anatomy, or other condition that impacts the performance of the device.Concomitant medical products: concomitant device(s): tibial insert 02-022-35-2009, tibial tray 02-022-45-2020, patella component 200-02-35.Additional product: cmnt simplex gent 6195-1-010.
Event or Problem Description
It was reported via exactech clinical study that the 51-year-old overweight caucasian female patient experienced ¿instability¿ total right knee arthroplasty.The date of event onset is on (b)(6) 2021.The patient is doing extremely well however the mechanical nature of her pain which previously consists of crepitus over her right knee is very excruciating and she would like to proceed with an alternative option; reluctant to proceed with a corticosteroid injection to the risk for infection and have instead offer her the opportunity for intra-articular arthroscopy to debride any scar tissue which may be present and causing a painful sensation.She has agreed to proceed accordingly.Action taken; right knee arthroscopy and debridement.The patients last known outcome is resolved on (b)(6) 2021.No additional information.
Additional Manufacturer Narrative
"(h3) pending evaluation" entered in the additional mfg narrative of the initial report was entered in error.No device return expected.

• Brand Name: TRULIANT KNEE COMPONENTS
• 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: 16008245
• Report Number: 1038671-2022-01609
• Device Sequence Number: 6656133
• Product Code: JWH
• UDI-Device Identifier: 10885862314529
• UDI-Public: 10885862314529
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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 Catalogue Number: 02-020-11-0320
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 05/14/2026
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/11/2023; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White