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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 306075283
• Report Number: 3013450937-2022-00400
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSC18100E0
• UDI-Public: B278KSC18100E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PART NUMBER 2500R004ELOT 1740214
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female