MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2511
Medical Device Problem Codes	Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-03-0225 - logic cr femoral cem, left sz 2.5: (b)(6), 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t: (b)(6).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.
Event or Problem Description
The patient previously underwent a left total knee arthroplasty.The patient later presented to the surgeon¿s office with complaints of pain, swelling, stiffness, decreased range of motion, and overall dissatisfaction with the knee replacement.As a result, the patient underwent revision surgery consisting of a tibial polyethylene insert and patellar component exchange.Patient was last known to be in stable condition following the event.No further information is available.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 11 MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24524916
• Report Number: 1038671-2026-00231
• Device Sequence Number: 8522936
• Product Code: JWH
• UDI-Device Identifier: 10885862159229
• UDI-Public: 10885862159229
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2023
• Device Catalogue Number: 02-012-49-2511
• 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: 02/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 01/14/2016
• 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: Hospitalization
• Patient Sex: Male