MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	02-012-44-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2017.Approximately 5 years and 5 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023.Diagnosis: failed right knee replacement secondary to wear of the bearing surface findings: at surgery, they did find scratching and loss of surface from the tibial insert, especially along the posterolateral margin.There was no gross delamination.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0340 - logic femoral ps cem right sz 4.(b)(6), 02-012-41-4040 - logic tibia traptray cem sz 4f/4t.(b)(6), 200-02-41 - three peg patella 41mm.Pending investigation.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17689622
• Report Number: 1038671-2023-02161
• Device Sequence Number: 20465965
• Product Code: JWH
• UDI-Device Identifier: 10885862173645
• UDI-Public: 10885862173645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 07/24/2020
• Device Catalogue Number: 02-012-44-4011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 06/05/2024; 01/08/2025
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 06/10/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2012
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male