MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; 14MM X 120MM STRAIGHT CANAL FILLING STEM

Model Number FS-14120-03M

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 08/20/2022

Event Type  Injury  

Event Description

It was reported that a patient experienced pain due to a loosened eleos segmental stem- the event was confirmed through radiographical imaging by the surgeon.The underwent revision surgery due to the loosened stem, approximately two years post-operatively.The patient was initially implanted with the eleos distal femur replacement system on (b)(6) 2020, and revised on (b)(6) 2022.This event will be reportable to the fda as a serious injury due to the revision surgery.The following devices were also removed and replaced: eleos distal femur, eleos tibial hinge, eleos axial pin, and an eleos poly spacer.No alleged issues were reported against these devices; therefore, they will be considered concomitant.

Event Description

It was reported that a patient experienced pain due to a loosened eleos segmental stem- the event was confirmed through radiographical imaging by the surgeon.The patient underwent revision surgery due to the loosened stem, approximately two years post-operatively.The patient was initially implanted with the eleos distal femur replacement system on 09 may 2020, and revised on 20 august 2022.This event will be reportable to the fda as a serious injury due to the revision surgery.The following devices were also removed and replaced: eleos distal femur, eleos tibial hinge, eleos axial pin, eleos male- female midsection, and an eleos poly spacer.No alleged issues were reported against these devices; therefore, they will be considered concomitant.

Manufacturer Narrative

It was reported that a patient underwent a revision surgery on 20 august 2022 due to the loosening of an eleos segmental stem.The patient's index surgery took place on 09 may 2020, where the patient was implanted with the eleos distal femur replacement system.The following devices were implanted: canal-filling straight segmental stem, poly spacer, stem extension, tibial baseplate, tibial hinge component, distal femur, male-female midsection, and a distal femur axial pin.During the revision surgery on 20 august 2022, the surgeon revised the 14x120mm canal-filling straight segmental stem to a 13x152mm cemented bowed segmental stem.The poly spacer, tibial hinge, distal femur, male-female midsection, and distal femur axial pin were also revised and there were no alleged issues with these devices.The patient was reported to be complaint, had poor bone quality, and did not experience any external trauma.The patient's activity level is unknown.Visual, dimensional, functional inspection and material analysis could not be conducted as the device was not returned for evaluation.The root cause of reported eleos segmental stem loosening could not be determined.It is possible that loosening could have occurred due to insufficient healing, residual post-operative motion, etc.The patient's poor bone quality could have contributed to the eleos canal-filling segmental stem loosening over time.However, a root cause could not be determined based on the available information.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: 14MM X 120MM STRAIGHT CANAL FILLING STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): PHILIPS PRECISION; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 15441856
• MDR Text Key: 300088144
• Report Number: 3013450937-2022-00258
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278FS1412003M0
• UDI-Public: B278FS1412003M0
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: FS-14120-03M
• Device Catalogue Number: FS-14120-03M
• Device Lot Number: 81694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female