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

Model Number	LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - lgc tibial fit tray cem sz 3.5f / 4.5t (cat# 02-012-45-3545 / serial# (b)(6)).- logic cr femoral por, left, sz 3.5 (cat# 02-010-04-0235 / serial# (b)(6)).- three peg patella 38mm (cat# 200-02-38 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately one year post patient's first tka revision, the 60 y/o male patient had a second revision for an unknown reason.All implants were removed.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 or x-rays.The devices are not available for evaluation as they were disposed by the hospital.
Additional Manufacturer Narrative
Additional information: b5.H3- according to the information provided, the patient had their left knee revised approximately 1 year following implantation due to an unknown reason.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.The cause of the revision cannot be conclusively determined.H6- clinical code, component code, investigation codes corrected information: h6- clinical code.
Event or Problem Description
This is the 2nd revision for the patient.The first revision was reported under mdr# 1038671-2023-00001.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.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.The cause of the revision cannot be conclusively determined.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 3.5, 9 MM
• 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: geoff gannon ; 3525541928
• MDR Report Key: 18234543
• Report Number: 1038671-2023-02882
• Device Sequence Number: 16970644
• Product Code: JWH
• UDI-Device Identifier: 10885862159243
• UDI-Public: 10885862159243
• 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: 2022
• 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): 04/16/2025

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 Model Number: LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-47-3509
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 08/19/2024; 04/15/2025
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 08/22/2024; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male