MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 1 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 1 11MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Joint Laxity (4526)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products - composant femoral logic a cimenter t.1 droit (cat# 02-010-01-0310 / serial# (b)(4).) - embase tibiale fit logic cimentee 1f/2t (cat# 02-012-45-1020 / serial# (b)(4).) - rotule 3 plots diam 35 8.5mm optetrak (cat# 200-02-35 / serial# (b)(4).) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately nine years post initial tka, the female patient had a full revision due to chronic hydratosis, moderate medial laxity and slight hyperextension.Synovitis was removed, a full lavage was performed, a tissue sampling was collected and total revision completed.Patient was revised to exactech devices.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 will be return.No other patient information/medical history reported.
Additional Manufacturer Narrative
(h3) the revision reported was likely due to the patient¿s reported conditions of chronic hydrarthrosis, moderate medial laxity, and slight hyperextension of the knee joint, as stated in the experience report.Additionally, the returned tibial insert appeared to exhibit signs of deformation and wear.This evaluation provides a visual review of the retrieved tibial insert, as provided.However, in absence of other supporting information (e.G., demographic data, radiographs from past follow-up visits, etc.), the sequence of events leading to the revision surgery cannot be established.The most probable root cause associated with the reported event of ¿instability¿ is associated with undesirable stability of the joint or implant construct.Furthermore, the most probable root cause associated with the event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d8, h2, h6: clinical code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusion.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 PS MOD INSRT SZ 1 11MM
• 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: 16725862
• Report Number: 1038671-2023-00661
• Device Sequence Number: 7209530
• Product Code: JWH
• UDI-Device Identifier: 10885862001696
• UDI-Public: 10885862001696
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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: 06/21/2020
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 1 11MM
• Device Catalogue Number: 02-012-35-1011
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 10/14/2025
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 08/16/2023; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female