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

Model Number FS-14120-03M

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Subluxation (4525)

Event Date 03/07/2022

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 288686285
• Report Number: 3013450937-2022-00118
• 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: 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
• 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
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2019
• 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: 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.
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female