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

Model Number LOGIC TIBIA PS MOD INSRT SZ 5 9MM

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: serial #: (b)(4), catalog #: 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t; serial #: (b)(4), catalog #: 200-02-38 - three peg patella 38mm; serial #: (b)(4), catalog #: 02-010-01-0350 - logic femoral ps cem right sz 5.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported via a legal notification that a male patient, initial right knee implanted on (b)(6) 2015, presented to their joint replacement institute for reasons unknown.Examination was performed and x-rays were taken.It was determined that the plaintiffs optetrak® device is failing at a much faster rate than expected making the artificial knee joint more prone to wearing out, loosening, and causing pain, muscle, nerve, and bone damage.This also significantly increases the likelihood that the joint will break.The plaintiff's surgeon recommended revision surgery to remove and replace the optetrak® device.No further information.

Manufacturer Narrative

H6: investigation results: the reason for the recommended revision cannot be determined, but it may be due to prosthesis wear as reported or may be related to the inclusion of the implanted polyethylene in the packaging recall.However, this cannot be confirmed as the devices are not available for evaluation as they remain implanted and limited information was available at the time of evaluation.

• Brand Name: LOGIC
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16194990
• MDR Text Key: 307591406
• Report Number: 1038671-2023-00041
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001924
• UDI-Public: 10885862001924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 5 9MM
• Device Catalogue Number: 02-012-35-5009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• 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
• Patient Sex: Male