MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 20MM THICKNESS

Model Number	25001220E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation.The investigation is in process.When the investigation is complete, a supplemental report will be submitted accordingly.Multiple mdrs were submitted for this event: # 3013450937-2021-00166, # 3013450937-2021-00167, # 3013450937-2021-00169, # 3013450937-2021-00170.This patient underwent another revision surgery on (b)(6) 2021 to remove and replace the following implants: tibial hinge component, tibial poly spacer, and resurfacing femur axial pin.The following mdrs are for the 3 implants that were revised on (b)(6) 2021: # 3013450937-2021-00171, # 3013450937-2021-00172, # 3013450937-2021-00173.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to an alleged infection.The following parts were removed and revised: resurfacing femur axial pin, tibial hinge component, tibial poly spacer.The following parts remain implanted from the original eleos surgery which took place on (b)(6) 2021: resurfacing femur, canal-filling stem extension (23mm x 100mm).The surgeon removed and revised the implants with poly components and performed a washout.No further information was made available.
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 could have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: 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 the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The following parts were removed and revised: resurfacing femur axial pin, tibial hinge component, tibial poly spacer.The following parts remain implanted from the original eleos surgery which took place on (b)(6) 2021: resurfacing femur, canal-filling stem extension (23mm x 100mm).The surgeon removed and revised the implants with poly components and performed a washout.No further information was made available.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, 20MM THICKNESS
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12349199
• Report Number: 3013450937-2021-00168
• Device Sequence Number: 5189838
• Product Code: KRO
• UDI-Device Identifier: B27825001220E0
• UDI-Public: +B27825001220E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 10/12/2021

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: 06/05/2026
• Device Model Number: 25001220E
• Device Catalogue Number: 25001220E
• Device Lot Number: 1751066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25002112E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N 2500R002E, ELEOS RESURFACING FEMUR; P/N KSP22100E, ELEOS STEM EXTENSION; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT; P/N 25002112E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N 2500R002E, ELEOS RESURFACING FEMUR; P/N KSP22100E, ELEOS STEM EXTENSION; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR