MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS; CANAL FILLING STEM, STRAIGHT, SPLINED 21MM X 120MM

Model Number	FS-21120-03M
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an eleos segmental stem loosened approximately 8 months post operatively.The patient underwent their index procedure on 02 march 2022, where the patient was implanted with the following devices: eleos canal filling stem, distal femur axial pin, tibial hinge, poly spacer, stem extension, distal femur, tibial baseplate, and a tibial baseplate tapered screw.During the patient's revision procedure on 23 november 2022, the loosened 21mm x 120mm canal filling stem was removed and replaced with a 15mm x 152mm cemented stem.The following devices were also replaced: poly spacer, distal femur, distal femur axial pin, and a tibial hinge.No issues were reported for these replaced devices.This event will be reportable to the fda as a serious injury due to the revision procedure.
Additional Manufacturer Narrative
It was reported that a patient's 21x120mm canal filling segmental stem had loosened.The patient underwent a revision surgery on 23 november 2022 where the surgeon revised the patient's 21x120mm eleos canal filling segmental stem to a 15x152mm cemented bowed segmental stem.The surgeon also revised the eleos poly spacer, eleos tibial hinge component, eleos distal femur axial pin, and eleos distal femur.There were no alleged malfunctions with the poly spacer, tibial hinge component, distal femur axial pin, and distal femur.Device history records were reviewed and no abnormalities were identified.It is possible that the alleged loosening could have occurred due to insufficient healing, residual post-operative motion, etc.However, as additional information regarding this event is not known, the root cause of this event could not be identified.

• Brand Name: ELEOS
• Common Device Name: CANAL FILLING STEM, STRAIGHT, SPLINED 21MM X 120MM
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 15992052
• Report Number: 3013450937-2022-00382
• Device Sequence Number: 12180518
• Product Code: KRO
• UDI-Device Identifier: B278FS2112003M0
• UDI-Public: B278FS2112003M0
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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 Model Number: FS-21120-03M
• Device Catalogue Number: FS-21120-03M
• Device Lot Number: 89851-008
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male