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

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 5269535 02-010-03-0340 - logic cr femoral cem, right, sz 4 5355987 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t 5310355 200-02-41 - three peg patella 41mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a patient, initial right knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2024, approximately 5 years 9 months post the initial procedure.The patient was revised due to pain and synovitis.Prosthesis wear was indicated.X-rays and device images were provided.No further information.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, which is confirmed from the images provided.Posterior edge loading was observed per the provided radiographs that may be the root cause of the wear, but that cannot be confirmed as the devices were not available for evaluation.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant patient demographic information was not provided.H6: corrected component, and investigation clinical codes.

• Brand Name: LOGIC
• 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: 18762996
• Report Number: 1038671-2024-00304
• Device Sequence Number: 4526058
• Product Code: JWH
• UDI-Device Identifier: 10885862230492
• UDI-Public: 10885862230492
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/10/2025

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: 10/15/2021
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM
• Device Catalogue Number: 02-012-51-4011
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/10/2025
• Date Device Manufactured: 10/17/2013
• 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
• Patient Sex: Unknown