MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STEM EXTENSION, 15X100MM

Model Number	KSP14100E
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an alleged dissociation of the resurfacing femur and stem extension and the stem extension fractured.The patient will be undergoing a revision surgery on (b)(6) 2023.No additional information regarding this event has been reported.
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.The following mdr has been submitted for the same adverse event: -3013450937-2023-00026.
Event or Problem Description
It was reported that the patient had an alleged dissociation of the resurfacing femur and stem extension and the boss of the resurfacing femur fractured.The patient underwent a revision surgery on (b)(6) 2023 to revise the implants to a compress system, custom adaptor, and distal femur implant.No additional information regarding this event has been reported.
Additional Manufacturer Narrative
This report is being submitted to include additional and corrected information.The investigation is complete.The root cause of the reported adverse event could not be definitively determined.The device was not returned for evaluation.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 4114: device not returned.H6: type of investigation code updated to 4117: device discarded.H6: type of investigation code updated to 4110: trend analysis.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: CANAL-FILLING STEM EXTENSION, 15X100MM
• 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
• MDR Report Key: 16383753
• Report Number: 3013450937-2023-00027
• Device Sequence Number: 20260349
• Product Code: KRO
• UDI-Device Identifier: B278KSP14100E0
• UDI-Public: B278KSP14100E0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/16/2023

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: 04/21/2025
• Device Model Number: KSP14100E
• Device Catalogue Number: KSP14100E
• Device Lot Number: 1703575
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• 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: P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION.; P/N 25001208E, ELEOS POLY SPACER.; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT.; P/N 25002114E, ELEOS RESURFACING FEMUR AXIAL PIN.; P/N 25002200E, ELEOS PROXIMAL TIBIA.; P/N 2500L004E, ELEOS RESURFACING FEMUR.; P/N 2500SP12E, ELEOS SEGMENTAL STEM.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 24 YR
• Patient Sex: Male