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

Catalog Number	02-012-45-5050
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Radiolucent Lines (4848); Joint effusion (4849)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, the 57 year old male patient had an initial left tka on (b)(6) 2015 and presented with lucency, 5 year(s) and 2 month(s) post initial procedure on (b)(6) 2020.Minor lucency detected on x-rays, under the medial tibial tray.The outcome of this event is considered continuing and the report indicates that the action taken is active monitoring with a review in 12 months.The case report form indicates that this event is definitely related to the device and/or to the procedure.The report also indicates that the action taken of active monitoring with a review in 12 months.The outcome is continuing.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 02-012-35-5011 logic tibia ps mod insrt sz 5 11mm.02-010-01-0250 logic femoral ps cem left sz 5.(h3) pending evaluation.
Additional Manufacturer Narrative
The tibial loosening reported was likely the result of an insufficient bond of the implant to the bone.However, the cause of the tibial loosening cannot be confirmed because no revision has been reported and no images/radiographs were provided.H6: corrected the following: medical device-problem code and component code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: e, f.The tibial loosening reported was likely the result of an insufficient bond of the implant to the bone.However, the cause of the tibial loosening cannot be confirmed because no revision has been reported and no images/radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK LOGIC 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18876679
• Report Number: 1038671-2024-00451
• Device Sequence Number: 20805131
• Product Code: JWH
• UDI-Device Identifier: 10885862004055
• UDI-Public: 10885862004055
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2026

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: 02-012-45-5050
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 06/04/2024; 05/23/2025; 07/21/2026
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 08/06/2024; 09/09/2024; 05/23/2025; 07/22/2026
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 115 LB