MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT WITHOUT ROTATIONAL STOP

Model Number	25002101E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs have been submitted for this adverse event: #3013450937-2023-00143.
Event or Problem Description
It was reported that the post of the patient's tibial hinge component fractured.The patient underwent a revision surgery on (b)(6) 2023 and the following implants were revised: tibial hinge component, poly spacer, and distal femur axial pin.Images of the explanted implants identified that there was damage to the top of the tibial poly spacer.It was reported that there was suspected metal debris from the tibial hinge component fracture.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and there were no non-conformances identified that would have contributed to this complaint.If additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: date of this report added date received by manufacturer added type of report added follow-up type added device evaluated by manufacturer updated to no type of investigation code updated to 3331: analysis of production records type of investigation code updated to 4110: trend analysis type of investigation code updated to 4109: historical data analysis investigation findings code updated to 3252: fracture problem investigation conclusions code updated to 4315: cause not established.
Event or Problem Description
It was reported that the post of the patient's tibial hinge component fractured.The patient underwent a revision surgery on (b)(6) 2023 and the following implants were revised: tibial hinge component, poly spacer, and distal femur axial pin.Images of the explanted implants identified that there was damage to the top of the tibial poly spacer.It was reported that there was suspected metal debris from the tibial hinge component fracture.No additional information regarding this adverse event has been reported.

• Brand Name: ELEOS
• Common Device Name: TIBIAL HINGE COMPONENT WITHOUT ROTATIONAL STOP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17367977
• Report Number: 3013450937-2023-00142
• Device Sequence Number: 7404925
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2023
• 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): 09/19/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25002101E
• Device Catalogue Number: 25002101E
• Device Lot Number: 1803752
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001050E, ELEOS MALE FEMALE MIDSECTION; P/N 25001070E, ELEOS MALE FEMALE MIDSECTION; P/N 25001208E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002201E, ELEOS TIBIAL BASEPLATE; P/N KSC01530E, ELEOS STEM EXTENSION
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 20 YR
• Patient Sex: Male