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

Catalog Number	02-012-51-3009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Arthrofibrosis (4885)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.D10.Concomitant products: (b)(6)- 02-010-03-0230 - logic cr femoral cem, left, sz 3.(b)(6)- 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6)- 02-012-51-3009 - logic tib insert impl crc, sz 3, 9mm.(b)(6)- 200-05-29 - inset patella 29mm.H3.Investigation results - logic tib insert impl crc, sz 3, 9mm with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition of arthrofibrosis.The revision surgery as associated with the implanted devices may be due to the patient illness, unique anatomy, or other condition that impacts the performance of the devices.There is no mention of device malfunction or wear in the revision operative report.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had an initial left knee total arthroplasty on (b)(6) 2019 and then approximately 1 year 5 months later on (b)(6) 2021 the patient had a surgical revision.Revision operative report of (b)(6) 2021 - postoperative diagnosis- failed knee due to arthrofibrosis.Patient was revised to competitor devices.Patient presented with a painful knee.Negative for infection.Full revision to allow rebound singh of the ligaments.Extensively debrided scar and synovial tissue from the medial and lateral gutters.The superficial and deep adhesions around the extensor mechanism to allow flexion of the knee were released.Tibial and femoral components were well fixed, they were removed.Patellar component was well fixed and left in place.The patient tolerated the procedure well.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: e1- facility name, h6 clinical codes, component code and types of investigation.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: geoff gannon ; gainesville, FL 32653
• MDR Report Key: 19028650
• Report Number: 1038671-2024-00717
• Device Sequence Number: 20879730
• Product Code: JWH
• UDI-Device Identifier: 10885862230409
• UDI-Public: 10885862230409
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 07/13/2023
• Device Catalogue Number: 02-012-51-3009
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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
• Patient Age: 55 YR
• Patient Sex: Female