MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 3, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	06/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 4.5 years post initial right tka, the female patient had a revision due to infection.The liner was exchanged.Patient was revised to exactech device.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation due the device was disposed at the hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately 4.5 years post initial right tka, the female patient had a revision due to infection.The liner was exchanged.Patient was revised to exactech device.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation due the device was disposed at the hospital.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues; no device information was provided.The cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6.The following sections were corrected: b2; h6, the reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17267371
• Report Number: 1038671-2023-01565
• Device Sequence Number: 5885560
• Product Code: JWH
• UDI-Device Identifier: 10885862174345
• UDI-Public: 10885862174345
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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: 06/07/2026
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3, 9MM
• Device Catalogue Number: 02-012-47-3009
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 03/16/2025
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 12/18/2023; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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: LGC TIBIAL FIT TRAY CEM SZ 3F / 3T.; LGC TIBIAL FIT TRAY CEM SZ 3F / 3T.; LOGIC CR FEMORAL POR, LEFT, SZ 3.; LOGIC CR FEMORAL POR, RIGHT, SZ 3.; LOGIC CR TIB INSERT STD, SZ 3, 9MM.; THREE PEG PATELLA 35MM (2).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female