MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER 10MM

Model Number 25001210E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 03/19/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Mulitple mdrs were submitted for this adverse event: 3013450937-2022-00136, 3013450937-2022-00137, 3013450937-2022-00138, 3013450937-2022-00139, 3013450937-2022-00140 and 3013450937-2022-00141.

Event Description

On (b)(6) 2022 the patient received a superficial wound debridement to treat a superficial suture and sub-q abscess that developed after receiving distal femoral replacement surgery.

Manufacturer Narrative

This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged infection could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4117: device not accessible for testing.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

Event Description

On (b)(6) 2022 the patient received a superficial wound debridement to treat a superficial suture and sub-q abscess that developed after receiving distal femoral replacement surgery.

• Brand Name: ELEOS
• Type of Device: TIBIAL POLY SPACER 10MM
• 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: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 14138159
• MDR Text Key: 289469811
• Report Number: 3013450937-2022-00135
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001210E0
• UDI-Public: B27825001210E0
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001210E
• Device Catalogue Number: 25001210E
• Device Lot Number: 1813665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• 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: 25000009E ELEOS DISTAL FEMUR RIGHT SEGMENTAL.; 25002111E ELEOS DISTAL FEMUR AXIAL PIN.; CS-13120-03M ELEOS SEGMENTAL STEM CEMENTED.; KSC01465E ELEOS STEM EXTENSION CEMENTED 14MMX65MM.; TB-2202E-01M ELEOS TIBIAL BASEPLATE SIZE 2.; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female