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

Catalog Number	02-022-35-2512
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Chills (2191); Implant Pain (4561); Medical device site infection (4845)
Date of Event	12/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: exactech truliant knee clinical study ;subject: (b)(6).It was reported via clinical study, that the 43 yo female patient was evaluated in the emergency department by the orthopedic surgery service due to 1-day of increasing left knee pain s/p left total knee arthroplasty on (b)(6) 2017.The patient presents to the emergency department with a fever of 102.7, tachycardic, a new white count of 11.3, and a crp of 114.The patient noted a fever to tmax 102 at home and increasing left knee pain with chills.Patient was admitted to the orthopedic surgery service for further monitoring/infectious workup and joint aspiration.The date of event onset it (b)(6) 2017.The patient¿s standard reverse shoulder system was revised to hemiarthroplasty.The outcome was last known as resolved on (b)(6) 2017.The case report form indicates this event is definitely not related to device and possibly related to procedure.
Additional Manufacturer Narrative
D10.Concomitants: truliant femoral component ref.No.(b)(4); tibial tray type cemented tibial tray ref.No.(b)(4); tibial stem extension ref.No.Patellar type standard; patella component ref.No.(b)(4); additional product ref.No.(b)(4) (simplex hv cement).
Additional Manufacturer Narrative
H3: 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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
D1: corrected brand name h6: corrected health effect - clinical code, health effect - impact code, medical device problem code, component code, investigation findings and investigation conclusions updated manufacturer narrative: based on review of all available information, there is no evidence to suggest that the reported event is related to any product problems or use issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, the reported infection may have been caused by a multitude of factors, which include: implant positioning, implant size selection, and/or patient-related factors (fitness for surgery, biomechanics, activity level).

• Brand Name: TRULIANT KNEE COMPONENTS
• 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 ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16753298
• Report Number: 1038671-2023-00705
• Device Sequence Number: 16960099
• Product Code: JWH
• UDI-Device Identifier: 10885862304193
• UDI-Public: 10885862304193
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

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: 02-022-35-2512
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 01/04/2024
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 01/29/2024; 09/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White