MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM; SEE H10

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Synovitis (2094); Joint Laxity (4526)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 6021592, 02-010-02-0235 - composant fem logic sans ciment t3.5 gauche.6628760, 02-012-45-3545 - embase tibiale fit logic a cimenter t3.5f/4.5t.5680212, 200-02-35 - rotule 3 plots diam 35 8.5mm optetrak.9000320191, a10012 - gps implant kit v2.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a patient, initial left knee implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2023, approximately 2 years 3 months post the initial procedure, due to evolving ml laxity & feeling of instability.There were signs of synovitis.The synovitis was removed, a full lavage was performed, a tissue sampling was collected & insert changed.There was no surgical delays reported.The patient was last known to be in stable condition following the event.The device is available for return.
Event or Problem Description
The revision reported may have be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis, which led to instability.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d1, d9, h3, h6 clinical code, device problem code, component code, type of investigation, investigation findings, investigation conclusion.The revision reported may have be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis, which led to instability.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
• 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: 16591318
• Report Number: 1038671-2023-00486
• Device Sequence Number: 2834809
• Product Code: JWH
• UDI-Device Identifier: 10885862173607
• UDI-Public: 10885862173607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 10/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2026
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
• Device Catalogue Number: 02-012-44-3511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 10/17/2025
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/31/2023; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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
• 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