MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS CANAL FILING STEM, STRAIGHT, 14MM X 120 MM

Model Number	FS-14120-03M
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery on(b)(6)2022.The patient had patella tracking issues due to loosening of an eleos canal filling stem post-operatively.This event will be reported as a serious injury due to revision procedure.During the revision procedure, the canal filling stem, distal femur axial pin, tibial hinge, and tibial polyspacer were replaced.No device specific issues were reported for the distal femur axial pin, tibial hinge, and tibial polyspacer; therefore, these devices are concomitant.This record captures the eleos canal filling stem.
Additional Manufacturer Narrative
It was reported that a patient experienced loosening of an eleos canal filling stem and had patella tracking issues.The patient was revised on (b)(6) 2022, to remove and replace the loosened canal filling stem with a cemented stem.During the revision procedure, the tibial hinge component, axial pin, and poly spacer were replaced, and the surgeon implanted a resurfacing patella.There were no alleged issues reported with the tibial hinge component, axial pin, and poly spacer.The root cause of the canal-filling segmental stem loosening and patella tracking issue could not be determined.From communication with the field representative, it was reported that the patient was not compliant.It is possible that loosening could have occurred due to insufficient healing, residual post-operative motion, etc.However, a root cause could not be determined based on the available information.A review of the work order and sterilization batch release record for the product involved found no indication that the implant loosening was a result of a manufacturing or sterilization nonconformance.A complaint trend was not identified.
Event or Problem Description
It was reported that a patient underwent revision surgery on (b)(6) 2022.The patient had patella tracking issues due to loosening of an eleos canal filling stem post-operatively.This event will be reported as a serious injury due to revision procedure.During the revision procedure, the canal filling stem, distal femur axial pin, tibial hinge, and tibial polyspacer were replaced.No device specific issues were reported for the distal femur axial pin, tibial hinge, and tibial polyspacer; therefore, these devices are concomitant.This record captures the eleos canal filling stem.

• Brand Name: ELEOS
• Common Device Name: ELEOS CANAL FILING STEM, STRAIGHT, 14MM X 120 MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 14023465
• Report Number: 3013450937-2022-00118
• Device Sequence Number: 5938318
• Product Code: KRO
• UDI-Device Identifier: B278FS1412003M0
• UDI-Public: B278FS1412003M0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/27/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2019
• 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: DISTAL FEMUR AXIL PIN, P/N 25000007E.; DISTAL FEMUR AXIL PIN, P/N 25000007E.; TIBIAL HINGE W/ STOP, P/N 25002100E.; TIBIAL HINGE W/ STOP, P/N 25002100E.; TIBIAL POLY SPACER 8MM, P/N 25001208E.; TIBIAL POLY SPACER 8MM, P/N 25001208E.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female