MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 6 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Joint effusion (4849)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: serial number, (b)(6), item number, 02-012-45-6050 and, full description, lgc tibial fit tray cem sz 6f / 5t, (b)(6), 02-010-01-0260 - logic femoral ps cem left sz 6, (b)(6), 200-02-41 - three peg patella 41mm.
Event or Problem Description
As reported, the patient had an inflammation on (b)(6) 2015.The patient presented on (b)(6) 2018 and after very active end of the year developed left knee effusion with pain.Effusion never went away so came in for f/u.Radiographic images showed no changes but noted effusion on lateral view.Aspiration negative for infection.Will continue to monitor.The case report form indicates that this event is possibly related to device, unlikely related to procedure.
Event or Problem Description
As reported, the patient had an inflammation.The patient presented symptoms to doctor and after a very active end of the year developed left knee effusion with pain.Effusion never went away so came in for f/u.Radiographic images showed no changes but noted effusion on lateral view.Aspiration negative for infection.Will continue to monitor.The reported event could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The reason for the joint effusion reported cannot be conclusively determined and the reported event could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 6 11MM
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17710200
• Report Number: 1038671-2023-02194
• Device Sequence Number: 20516075
• Product Code: JWH
• UDI-Device Identifier: 10885862001979
• UDI-Public: 10885862001979
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: 12/19/2022
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 6 11MM
• Device Catalogue Number: 02-012-35-6011
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 117 KG