MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL BASEPLATE, SIZE 4

Model Number 25002204E

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The patient had eleos components revised during a revision surgery. The tibial baseplate was not revised. The sales representative stated that the patient pulled out the surgical drain after the prior surgery. He reported that this led to a revision surgery. He stated that there was no failure of the tibial baseplate component. No other information is available at this time. If more information is obtained, a supplement report will be submitted, multiple mdrs were submitted for this event: 3013450937-2021-00084, 3013450937-2021-00086, 3013450937-2021-00087, 3013450937-2021-00088, 3013450937-2021-00089, 3013450937-2021-00090, 3013450937-2021-00091.

Event Description

The patient involved in this complaint underwent a revision surgery on (b)(6) 2021 performed by dr. (b)(6). It was reported by the sales representative that the patient pulled out their surgical drain when the drain was supposed to remain in the patient according to post-operative instructions. The drain was placed on (b)(6) 2021 during a surgery performed by dr. (b)(6) to place eleos components for an unknown reason. During the revision surgery, the patient had eleos components explanted and replaced. There was no reported failure of the eleos components. It is unknown at this time why the components were replaced. No further information is available at this time.

• Brand Name: ELEOS
• Type of Device: TIBIAL BASEPLATE, SIZE 4
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 11866602
• MDR Text Key: 252142454
• Report Number: 3013450937-2021-00085
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 25002204E
• Device Catalogue Number: 25002204E
• Device Lot Number: 1801193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/21/2021 Patient Sequence Number: 1