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

Model Number 25001208E

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

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

Event Date 01/06/2023

Event Type  Injury  

Event Description

Patient was revised on (b)(6) 2023 due to an alleged infection.During this revision surgery the following implants were revised: eleos tibial hinge component, eleos tibial poly spacer, and eleos distal femur axial pin.No additional information regarding this adverse event has been provided.

Manufacturer Narrative

The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this adverse event: 3013450937-2023-00015, 3013450937-2023-00017, 3013450937-2023-00018, 3013450937-2023-00019, 3013450937-2023-00020, 3013450937-2023-00021, 3013450937-2023-00022, 3013450937-2023-00023, 3013450937-2023-00024 and 3013450937-2023-00025.The following mdr was also submitted for this patient: 3013450937-2021-00061.

Event Description

Patient was revised on (b)(6) 2023 due to an alleged infection.During this revision surgery the following implants were revised: eleos tibial hinge component, eleos tibial poly spacer and eleos distal femur axial pin.No additional information regarding this adverse event has been provided.

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: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELEOS
• Type of Device: TIBIAL POLY SPACER
• 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, NJ 07054 ; 8447672766
• MDR Report Key: 16297139
• MDR Text Key: 308787064
• Report Number: 3013450937-2023-00016
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001208E0
• UDI-Public: B27825001208E0
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001208E
• Device Catalogue Number: 25001208E
• Device Lot Number: 1813664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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.; 25001070E ELEOS MALE-FEMALE MIDSECTION, 70MM.; 25001090E ELEOS MALE-FEMALE MIDSECTION, 90MM.; 25001110E ELEOS MALE-FEMALE MIDSECTION, 110MM.; 25002100E ELEOS TIBIAL HINGE COMPONENT.; 25002111E ELEOS DISTAL FEMUR AXIAL PIN.; 25002205E ELEOS TIBIAL BASEPLATE, SIZE: 5.; KSP13140E ELEOS STEM EXTENSION, CANAL FILLING.; MS-070MM-02M ELEOS MALE-MALE MIDSECTION, 70MM.; PF-2000R-02M ELEOS PROXIMAL FEMUR, 98MM, RIGHT.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male