MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-48-3509
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	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years post op the initial left tka, this 75 y/o male patient was revised due to deep infection.No breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.Concomitant medical products: logic cr femoral cem, left, sz 3.- 02-010-03-0235, (b)(4).Three peg patella 41mm - 200-02-41, (b)(4).Lgc tibial fit tray cem sz 3.5f / 4.5t - 02-012-45-3545, (b)(4).
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 5 years post op the initial left tka, this 75 y/o male patient was revised due to deep infection.The patient was revised to exactech devices.No breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Devices are not returning; disposed of by hospital.No additional information.
Event or Problem Description
As reported, approximately 5 years post op the initial left tka, this 75 y/o male patient was revised due to deep infection.The patient was revised to exactech devices.No breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Devices are not returning; disposed of by hospital.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d6a, d8, h6: annex b, c, d, e, g.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 SLOPE +. SZ 3.5, 9 MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15454691
• Report Number: 1038671-2022-01141
• Device Sequence Number: 20585799
• Product Code: JWH
• UDI-Device Identifier: 10885862159281
• UDI-Public: 10885862159281
• 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: 2017
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 02/18/2026

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: 12/17/2024
• Device Model Number: 02-012-48-3509
• Device Catalogue Number: 02-012-48-3509
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 02/09/2026
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/01/2022; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male