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

Catalog Number	02-012-44-4011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Synovitis (2094)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had an initial left knee total arthroplasty on (b)(6) 2015 and then approximately 7 years, 6 months later on (b)(6) 2022 the patient experienced an arthroscopic procedure.Arthroscopic procedure operative report of (b)(6) 2022- postoperative diagnosis ¿ debris synovitis status post left total knee replacement.Name of operation: 1.Arthroscopy 2.Debridement.3.Removal scar tissue 4.Synovectomy left knee.The patient had significant debris synovitis.There was no loosening of the prosthesis, femur, tibia, or patella.No intraoperative complications.There were no radiographic or other images provided.There was no revision of devices.There is no other information available.
Additional Manufacturer Narrative
H10.H6.Investigation results - tibial insert implanted (b)(6) 2015, insert manufactured date 04-aug-2014.The cause of the patient¿s synovitis and subsequent arthroscopic procedure 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.As noted in the operative report, there was no loosening of the prosthesis, femur, tibia, or patella, there was no revision of devices.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d1, d4 (remove all from initial report-suspect device unknown), g2 (initial report), g4 (remove 501k-unknown), h4 (remove from initial report), h6: clinical codes, impact code, component code, types of ivestigation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC KNEE SYSTEM
• 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: michael crader
• MDR Report Key: 18651160
• Report Number: 1038671-2024-00160
• Device Sequence Number: 12828012
• Product Code: JWH
• UDI-Device Identifier: 10885862173645
• UDI-Public: 10885862173645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2026

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 Expiration Date: 07/31/2022
• Device Catalogue Number: 02-012-44-4011
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Male