MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; SEE H10

Model Number LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Synovitis (2094); Swelling/ Edema (4577)

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported that a patient, initial left knee implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2024, approximately 8 years 10 months post the initial procedure.The patient was revised due to synovitis and swelling to a new size 9 insert.There were no issues with surgery.The explants are not available for return.X-rays and device images were provided.No further information.

Manufacturer Narrative

D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: (b)(6)- 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)- 200-02-35 - three peg patella 35mm.(b)(6)- 201-46-10 - holding pin headless 3" (4 pk).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: OPTETRAK LOGIC
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927461
• MDR Text Key: 337945539
• Report Number: 1038671-2024-00554
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862159144
• UDI-Public: 10885862159144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/18/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• Device Catalogue Number: 02-012-47-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/18/2024
• Date Device Manufactured: 10/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0021-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention