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

Model Number	LOGIC CC TIB INSERT SIZE 4, 15MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a cc clinical study, that a 65 yo male patient, initial right knee implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2022.Approximately 2 years 4 months post the initial procedure due to infection.The patient had an inflammatory response to the prosthesis.Poly fail indicated.The patient was revised to a non exactech device.The study indicates the event was definitely related to the devices and the procedure.The event was resolved on (b)(6) 2022.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 4948440, 02-010-06-0340 - logic cc femoral size 4, right.5448042, 02-012-64-1412 - tru fluted stm ext 14mm x120mm blast.5560513, 02-012-64-2012 - tru fluted stm ext 20mm x120mm blast.6331246, 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t.6371861, 200-02-38 - three peg patella 38mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• 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: kate jacobson ; 3523771140
• MDR Report Key: 17002550
• Report Number: 1038671-2023-01140
• Device Sequence Number: 17787014
• Product Code: JWH
• UDI-Device Identifier: 10885862266132
• UDI-Public: 10885862266132
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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 Model Number: LOGIC CC TIB INSERT SIZE 4, 15MM
• Device Catalogue Number: 02-012-65-4015
• 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: 04/21/2023
• Initial Report FDA Received Date: 05/25/2023
• Date Device Manufactured: 07/12/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 157 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White