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

Catalog Number 02-012-65-5021

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

Concomitants medical products: serial #: (b)(4), category #: 208-05-05 - cc distal fem augment sz 5, 5mm.Serial #: (b)(4), category #: 208-05-05 - cc distal fem augment sz 5, 5mm.Serial #: (b)(4), category #: 02-010-06-0551 - logic post.Aug.Block size 5, 5mm.Serial #: (b)(4), category #: 02-010-06-0350 - logic cc femoral size 5, right.Serial #: (b)(4), category #: 400-40-11 - flex osteotome-round, me.Serial #: (b)(4), category #: 02-012-60-1440 - logic stem ext 14mm x 40mm.Serial #: (b)(4), category #: 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.Serial #: (b)(4), category #: 02-012-61-4202 - logic off stm ext 20mm x 120l x 4mm offset.Serial #: (b)(4), category #: 02-012-66-2000 - metaphyseal tibial cone, ml32mm.

Event Description

It was reported post-operative via clinical study that the 55 yo male patient underwent revision surgery of primary total knee on (b)(6) 2018 due to an infection (right knee i&d with liner exchange).The date of event onset is (b)(6) 2018.The patient¿s outcome was last known as resolved.

Manufacturer Narrative

H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues; no device information was provided.The cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.

• 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: 16546117
• MDR Text Key: 311321937
• Report Number: 1038671-2023-00444
• Device Sequence Number: 1
• Product Code: JWH
• 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,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Catalogue Number: 02-012-65-5021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Race: White