MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left knee was revised approximately 9 years post op.Patient complained of pain.Loose femoral component, recalled insert and patella.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 4118286 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.2991565 201-78-81 - 3" trocar, mod.Hex 2pk.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear over the course of 9 years of implantation and possible contributions from patient-related factors.An additional reason for the reported revision may be femoral loosening; however, this could not be confirmed from the provided information.Additional potential contributions to the event could not be assessed as the devices were not available for evaluation and limited information was provided.H6: corrected investigation clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 11MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20615263
• Report Number: 1038671-2024-04256
• Device Sequence Number: 8820653
• Product Code: JWH
• UDI-Device Identifier: 10885862001931
• UDI-Public: 10885862001931
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: 02-012-35-5011
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 04/16/2025
• Date Device Manufactured: 03/11/2014
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 85 KG