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

Catalog Number 02-012-60-1480

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported via clinical study, that (post-op) the 54 yo white male patient experienced pain in the right knee due to infection.The patient¿s outcome was last known as continuing.The case report form indicates this event is definitely not related to device and definitely not related to procedure.

Manufacturer Narrative

Concomitant medical products: 02-010-06-0340 - logic cc femoral size 4, right; 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; 02-012-60-1425 - logic stem ext 14mm x 25mm; 200-02-35 - three peg patella 35mm.

• Brand Name: OPTETRAK 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16531000
• MDR Text Key: 311218018
• Report Number: 1038671-2023-00426
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862272140
• UDI-Public: 10885862272140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150890
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02-012-60-1480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White