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

Catalog Number 200-02-35

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 02-012-60-1812 - logic stem ext 18mm x 120mm; 208-06-02 - cc distal fem augment sz 2, 10mm; 02-010-06-0521 - logic post.Aug.Block size 2, 5mm.

Event Description

It was reported via clinical study that the 52 yo white male patient had an infection.The patient was treated with joint effusion, debridement & irrigation.The patient¿s outcome was last known as resolved on (b)(6) 2022.Is this a revision surgery? yes.Indication for revision surgery: infection, two stage surgical management it was reported via clinical study that the 52 yo white male patient had an infection that continued.The patient was admitted to hospital for spacer revision surgery on (b)(6) 2021.The patient¿s outcome was last known as resolved on (b)(6) 2022.Indication for revision surgery: infection, two stage surgical management.(2nd part of the procedure -removal of the antibiotic spacer and implanting new devices).

Manufacturer Narrative

H3: 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
• 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: 16530473
• MDR Text Key: 311218372
• Report Number: 1038671-2023-00425
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932690
• 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: 09/28/2023

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 Expiration Date: 01/14/2021
• Device Catalogue Number: 200-02-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White