MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STEM EXTENSION, 18X100MM

Model Number	KSP17100E
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to an alleged loosening of the patient's canal-filling segmental stem.During the revision surgery, the canal-filling segmental stem was revised to a cemented straight segmental stem.The following eleos implants were also revised: distal femur, male-female midsection, tibial hinge component, and distal femur axial pin.Attempts were made and no further information was made available.
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted to include additional and corrected 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 were likely to have contributed to this adverse event.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated/corrected: b4: date of this report added.B5: event description corrected.B7: relevant history updated.D2: common device name corrected.D4: additional device information updated.D6a: implanted date updated.D10: concomitant medical products updated.G1: manufacturing site for devices updated.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4109: historical data analysis.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to an alleged loosening of the patient's 18x100mm canal-filling stem extension.During the revision surgery, the patient's resurfacing femur, resurfacing femur axial pin, and 18x100mm canal-filling stem extension were revised to a distal femur, distal femur axial pin, and 13x120mm cemented segmental stem.The following implants were also revised: tibial hinge component and tibial poly spacer.There were no alleged malfunctions with the resurfacing femur, resurfacing femur axial pin, tibial hinge component, and tibial poly spacer.No additional information regarding this event has been reported.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING STEM EXTENSION, 18X100MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: sara dailey ; 5677 airline rd; arlington, TN 38002 ; 8447672766
• MDR Report Key: 16915338
• Report Number: 3013450937-2023-00074
• Device Sequence Number: 6375969
• Product Code: KRO
• UDI-Device Identifier: B278KSP17100E0
• UDI-Public: B278KSP17100E0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/22/2023

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: 04/10/2026
• Device Model Number: KSP17100E
• Device Catalogue Number: KSP17100E
• Device Lot Number: 1734145
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• 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 2500R004E, ELEOS RESURFACING FEMUR.; P/N FS-13120-03M, ELEOS SEGMENTAL STEM.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male