MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CEMENTED, 14MMX65MM, STRAIGHT, FLUTED

Model Number	KSC01465E
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	08/01/2022
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: 3013450937-2022-00245, 3013450937-2022-00246, 3013450937-2022-00247, 3013450937-2022-00248, 3013450937-2022-00249, 3013450937-2022-00250, 3013450937-2022-00252 and 3013450937-2022-00253.
Event or Problem Description
It was reported that a patient experienced an infection and underwent a revision surgery on (b)(6) 2022.The following implants were removed during the revision: eleos distal femur axial pin, eleos tibial hinge w/ rotational stop and eleos tibial poly spacer.
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.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.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 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.
Event or Problem Description
It was reported that a patient developed an alleged infection and underwent a revision surgery on (b)(6) 2022.The following implants were removed during the revision: eleos distal femur axial pin, eleos tibial hinge w/ rotational stop and eleos tibial poly spacer.The following implants remain implanted from this patient's original surgery: eleos distal femur, two eleos tibial block augments, eleos cemented stem extension, eleos segmental stem, and eleos tibial baseplate.No additional information regarding this adverse event has been reported.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CEMENTED, 14MMX65MM, STRAIGHT, FLUTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 15332466
• Report Number: 3013450937-2022-00251
• Device Sequence Number: 6937692
• Product Code: KRO
• UDI-Device Identifier: B278KSC01465E0
• UDI-Public: B278KSC01465E0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/23/2022

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: KSC01465E
• Device Catalogue Number: KSC01465E
• Device Lot Number: 1866005
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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: 25000007E ELEOS DISTAL FEMUR, LEFT, SEGMENTAL; 25001208E ELEOS TIBIAL POLY SPACER 8MM; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; CS-15120-03M ELEOS CEMENTED SEGMENTAL STEM; KTAGB305E ELEOS TIBIAL BLOCK AUGMENT SIZE: 3; KTAGB305E ELEOS TIBIAL BLOCK AUGMENT SIZE: 3; TB-2203E-01M ELEOS TIBIAL BASEPLATE SIZE: 3; THSMWRS01M ELEOS TIBIAL HINGE W/ROTATIONAL STOP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female