MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent an initial right total knee arthroplasty due to gonarthrosis.The patient reported the onset of painful symptoms with gonalgia and associated functional limitation, for which they presented to the emergency room.On this occasion x-rays were taken that showed signs of prosthetic mobilization.Samples were taken for culture tests and a chemical-physical examination, and the patient was placed on the waiting list for a two-stage surgical revision.Upon admission for prosthetic removal, new x-rays confirmed the mobilization.Approximately six years post the initial total knee arthroplasty, and five days after the patient visit to the emergency room, the patient underwent surgery for the explantation of the knee prosthesis and the placement of an articulated cemented spacer.During the surgery, samples were taken for culture tests, which returned negative results; the prosthetic components were sent for sonication and culture examination.Intraoperatively, there was a clear mobilization of the femoral component and a significant villous synovial infiltrate.An articulated cemented spacer was implanted, and the patient is currently awaiting surgery for the removal of the spacer and total knee prosthesis revision.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(6).
Additional Manufacturer Narrative
Report number: 1038671-2024-01906 this follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of aseptic loosening between the femoral component and the bone.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear.However, the contributions of each to the sequence of events cannot be confirmed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d4 serial and expiration date no longer applies.H4 manufacturing date no longer applies.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d8, h3, h6 type of investigation.This follow-up report is being submitted to relay additional information.The following sections were updated: d9.H3: the revision reported was likely the result of aseptic loosening between the femoral component and the bone.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in third body prosthesis wear of the insert.Mild deformation of the patellar component consistent with normal implantation was noted.However, the contributions of femoral loosening and tibial insert wear to the sequence of events cannot be confirmed.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21102007
• Report Number: 1038671-2025-00147
• Device Sequence Number: 15617632
• Product Code: JWH
• UDI-Device Identifier: 10885862001887
• UDI-Public: 10885862001887
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/24/2025

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: 10/12/2025
• Device Catalogue Number: 02-012-35-4009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 01/10/2025; 06/12/2025; 07/22/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/13/2025; 06/26/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male