MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CANAL FILLING, SIZE: 14MM X 140MM STRAIGHT, SPLINED, SLOTTED

Model Number	KSP13140E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional 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, 3013450937-2023-00016, 3013450937-2023-00017, 3013450937-2023-00018, 3013450937-2023-00019, 3013450937-2023-00020, 3013450937-2023-00021, 3013450937-2023-00022, 3013450937-2023-00024 and 3013450937-2023-00025.The following mdr was also submitted for this patient: 3013450937-2021-00061.
Event or Problem 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.
Event or Problem 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.
Additional 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: 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.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CANAL FILLING, SIZE: 14MM X 140MM STRAIGHT, SPLINED, SLOTTED
• 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: 16297186
• Report Number: 3013450937-2023-00023
• Device Sequence Number: 7549173
• Product Code: KRO
• UDI-Device Identifier: B278KSP13140E0
• UDI-Public: B278KSP13140E0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: KSP13140E
• Device Catalogue Number: KSP13140E
• Device Lot Number: 1711380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 25000009E ELEOS DISTAL FEMUR, RIGHT, SEGMENTAL; 25001070E ELEOS MALE-FEMALE MIDSECTION, 70MM; 25001090E ELEOS MALE-FEMALE MIDSECTION, 90MM; 25001110E ELEOS MALE-FEMALE MIDSECTION, 110MM; 25001208E ELEOS TIBIAL POLY SPACER; 25002100E ELEOS TIBIAL HINGE COMPONENT; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; 25002205E ELEOS TIBIAL BASEPLATE, SIZE: 5; MS-070MM-02M ELEOS MALE-MALE MIDSECTION, 70MM; PF-2000R-02M ELEOS PROXIMAL FEMUR, 98MM, RIGHT
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 26 YR
• Patient Sex: Male