MAUDE Adverse Event Report: Exactech, Inc. LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	02-012-35-3511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 10 years and 4 months post the initial right total knee arthroplasty, the patient was revised due to tibial and patellar wear.The patella poly showed significant wear with mild osteolysis of the bone; no bone graft required.There was moderate wear on the tibial insert.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 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, Inc.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: julia ; 2320 nw 66th ct; gainesville, FL 32653 ; +1 (352) 377-1140
• MDR Report Key: 50113634
• Report Number: 1038671-2026-00970
• Device Sequence Number: 16007422
• Product Code: JWH
• UDI-Device Identifier: 10885862001856
• UDI-Public: 10885862001856
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 08/03/2026

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: 11/03/2022
• Device Catalogue Number: 02-012-35-3511
• 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: 07/19/2026
• Initial Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 11/06/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: See H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male