MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM- CANAL FILLING 12MM X 152MM

Model Number	FB-12152-03M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was identified on (b)(6) 2023, that a patient underwent revision on (b)(6) 2021.During this revision surgery, the following implants were revised: eleos distal femur axial pin, distal femur, male-female midsection, and cemented segmental stem.The reason for this revision surgery is unknown at the time of this report.If additional information is received, a supplemental report will be submitted accordingly.This event will be reportable to the fda as a serious injury due to the revision surgery.This record captures the revised eleos segmental stem.
Additional Manufacturer Narrative
Additional details regarding this event is not available at the time of this report.If additional information is received a supplemental will be submitted accordingly.The following mdrs were submitted for this event: 3013450937-2023-00126, 3013450937-2023-00127, 3013450937-2023-00128.
Event or Problem Description
It was identified on (b)(6) 2023, that a patient underwent revision on (b)(6) 2021.During this revision surgery, the following implants were revised: eleos distal femur axial pin, eleos distal femur, eleos male-female midsection, and eleos cemented segmental stem.The reason for this revision surgery is unknown.This event will be reportable to the fda as a serious injury due to the revision surgery.This record captures the revised eleos cemented segmental stem.Update on 11 october 2023: upon investigation conclusion, additional information was not identified regarding this event.
Additional Manufacturer Narrative
The patient's index surgery occurred on (b)(6) 2019, where the following eleos implants were implanted: eleos distal femur, eleos tibial hinge component, eleos male-female midsection, eleos tibial baseplate, eleos tibial poly spacer, eleos distal femur axial pin, and eleos canal filling segmental stem.It was identified that the patient had undergone a previous revision in (b)(6) 2021.The following implants were removed and replaced: eleos distal femur, eleos distal femur axial pin, eleos male-female midsection, and eleos segmental stem.The reason for this revision is unknown.The root cause for this event could not be determined as the failure mode and event details are not known.Devices in scope of this complaint were not returned for evaluation.Therefore, visual, dimensional, functional and material analysis could not be conducted.Work orders and sterilization batch records were reviewed, and no issues related to the manufacturing of the devices were observed.Previous complaint history review not be conducted as the failure of this event is not known.The following mdrs were submitted for this event: 3013450937-2023-00126; 3013450937-2023-00127; 3013450937-2023-00128; 3013450937-2023-00129; 3013450937-2023-00126-001; 3013450937-2023-00127-001; 3013450937-2023-00128-001; 3013450937-2023-00129-001.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM- CANAL FILLING 12MM X 152MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 17357981
• Report Number: 3013450937-2023-00129
• Device Sequence Number: 6903313
• Product Code: KRO
• UDI-Device Identifier: B278FB1215203M0
• UDI-Public: B278FB1215203M0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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 Model Number: FB-12152-03M
• Device Catalogue Number: FB-12152-03M
• Device Lot Number: 82292
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female