MAUDE Adverse Event Report: EXACTECH, INC. LOGIC KNEE COMPONENTS; SEE H10

Model Number	LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Synovitis (2094); Swelling/ Edema (4577)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial left knee implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2024, approximately 8 years 10 months post the initial procedure.The patient was revised due to synovitis and swelling to a new size 9 insert.There were no issues with surgery.The explants are not available for return.X-rays and device images were provided.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: (b)(6)- 02-010-03-0225 - logic cr femoral cem, left sz 2.5.(b)(6)- 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.(b)(6)- 200-02-35 - three peg patella 35mm.(b)(6)- 201-46-10 - holding pin headless 3" (4 pk).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b1, b2, d1, d4 (remove all data from initial report - catalog number unknown) g1, g4 (remove date), h4 (remove date) h6: component code, type of investigation, investigation findings and investigation conclusions.The revision reported was likely the result of swelling and synovitis.Localized prosthesis wear was noted on the image of the tibial insert, but it cannot be determined if this contributed to the synovitis, swelling, and/or reason for the revision.The reason for the swelling and synovitis cannot be conclusively determined because the device was not returned for evaluation and relevant patient information was not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC KNEE COMPONENTS
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927461
• Report Number: 1038671-2024-00554
• Device Sequence Number: 19981344
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• 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): 01/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown