MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-010-01-0240

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Bacterial Infection (1735)

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 02-012-35-4011 - logic tibia ps mod insrt sz 4 11mm.200-02-35 - three peg patella 35mm.02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.(h3) pending evaluation.

Event Description

As reported by the exactech knee replacement study, the 66-year-old male patient had a left tka on (b)(6) 2012.The patient presented with effusion / lucency - mild effusion to the left knee and mild lucencies under the anterior flange.The outcome of this event is considered continuing and the report indicates that the action taken is other - monitor.Review in 12 months.The case report form indicates that this event is definitely related to the device and to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 4
• Type of Device: 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18918711
• MDR Text Key: 337844029
• Report Number: 1038671-2024-00524
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001160
• UDI-Public: 10885862001160
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

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 Catalogue Number: 02-010-01-0240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 93 KG