MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3511
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-03-0335 - logic cr femoral cem, right, sz 3.5: (b)(6), 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t: (b)(6), 200-02-35 - three peg patella 35mm: (b)(6), should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient, who had a right tka, underwent a revision procedure approximately 7 years 3 months post the initial procedure.The patient presented to the surgeon with complaints of pain, stiffness, swelling, decreased motion, and dissatisfaction.The patient had a recalled knee polyethylene liner, which was worn out on the x-ray.The patient underwent a poly insert swap from a slope ++ to a crc activit-e implant.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted device is not available for return as it is handled by the hospital.A device image was provided.No further information.

• Brand Name: OPTETRAK LOGIC
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: katy priest ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25224572
• Report Number: 1038671-2026-00623
• Device Sequence Number: 13211803
• Product Code: JWH
• UDI-Device Identifier: 10885862159328
• UDI-Public: 10885862159328
• 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 Implanted Year: 2019
• 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): 05/19/2026

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: 10/02/2023
• Device Catalogue Number: 02-012-49-3511
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• 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; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male