MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS LIMB SALVAGE SYSTEM; ELEOS CEMENTED STEM EXTENSION 18MM X 100MM, STRAIGHT, FLUTED

Model Number	CS-17120-03M
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with the eleos proximal tibia replacement system on (b)(6) 2019.On (b)(6) 2022, over two years post-operatively, the patient was revised.It was reported that the patient's eleos straight cemented stem had dissociated from the eleos resurfacing femur.The following implants were implanted on (b)(6) 2019: eleos male-female midsection, eleos cemented straight stem, eleos tibial hinge component, eleos tibial poly spacer, eleos proximal tibia, eleos resurfacing femur, eleos resurfacing femur axial pin, and eleos stem extension.During the patient's revision surgery on (b)(6) 2022 the following implants were placed: eleos stem extension, eleos tibial poly spacer, eleos distal femur axial pin, eleos distal femur, eleos segmental stem, eleos locking ring, eleos male femal midsection, and eleos tibial hinge.No issues were reported against the remaining devices.This event will be reportable to the fda as a serious injury.This report captures the dissociated eleos straight cemented stem.
Additional Manufacturer Narrative
A patient was implanted with the eleos proximal tibia replacement system on (b)(6) 2019.On (b)(6) 2022, over two years post-operatively, the patient was revised.It was reported that the patient's eleos cemented stem extension had dissociated from the eleos resurfacing femur.The devices were not returned for evaluation.As the devices were implanted for approximately two years, it is possible that residual post-operative motion could have contributed to the issue.However, the root cause for the dissociation could not be determined definitively.Two mfrs were reported due to this event: 3013450937-2023-00400; 3013450937-2023-00401.
Event or Problem Description
A patient was implanted with the eleos proximal tibia replacement system on (b)(6) 2019.On (b)(6) 2022, over two years post-operatively, the patient was revised.It was reported that the patient's eleos straight cemented stem had dissociated from the eleos resurfacing femur.The following implants were implanted on (b)(6) 2019: eleos male-female midsection, eleos cemented straight stem, eleos tibial hinge component, eleos tibial poly spacer, eleos proximal tibia, eleos resurfacing femur, eleos resurfacing femur axial pin, and eleos stem extension.During the patient's revision surgery on (b)(6) 2022 the following implants were placed: eleos stem extension, eleos tibial poly spacer, eleos distal femur axial pin, eleos distal femur, eleos segmental stem, eleos locking ring, eleos male femal midsection, and eleos tibial hinge.No issues were reported against the remaining devices.This event will be reportable to the fda as a serious injury.This report captures the dissociated eleos straight cemented stem.On 17 march 2023 update: additional information was received and it was determined that the patient's eleos stem extension had disassociated from the eleos resurfacing femur, not the eleos straight cemented stem.This record now captures the eleos stem extension.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS CEMENTED STEM EXTENSION 18MM X 100MM, STRAIGHT, FLUTED
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd.; parsippany, NJ 07054
• MDR Report Key: 16038545
• Report Number: 3013450937-2022-00400
• Device Sequence Number: 12558852
• Product Code: KRO
• UDI-Device Identifier: B278KSC18100E0
• UDI-Public: B278KSC18100E0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 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): 03/17/2023

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: CS-17120-03M
• Device Catalogue Number: KSC18100E
• Device Lot Number: 1750157
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PART NUMBER 2500R004ELOT 1740214
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female