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

Catalog Number 02-012-45-2020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

Concomitants: 02-010-06-0320 femoral component.02-012-44-2015 tibial polyethylene insert.02-012-60-1440 tibial stem extension.02-012-60-1880 stem extension.208-05-02 femoral augment 1 catalog.208-06-02 femoral augment 2 catalog.02-012-66-2000 tibial cone 1.

Event Description

It was reported via clinical study, that the 61 yo female patient had an wound infection with swelling & discharge from right knee.The wound cultures grew staph haemolyticus, enterococcus faecalis, corynebacterium.(inpatient/prolonged hospitalization).The adverse event date of onset is (b)(6) 2017.The patient was treated with medication.The patient¿s outcome was last known as resolved on (b)(6) 2017.

• 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: 16587769
• MDR Text Key: 311736316
• Report Number: 1038671-2023-00475
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862003904
• UDI-Public: 10885862003904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101981
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02-012-45-2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 77 KG