MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 8MM

Model Number 25001208E

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2023-00189.

Event Description

It was reported that the patient's tibial hinge component dislocated from the tibial poly spacer.The patient underwent a revision surgery where the following eleos implants were revised: distal femur axial pin, poly spacer, and tibial hinge component.No additional information has been reported.

Manufacturer Narrative

The patient underwent a revision surgery on (b)(6) 2023 due to the patient's tibial hinge component dislocated from the tibial poly spacer.During the revision surgery, the following eleos implants were revised: poly spacer and tibial hinge component.A review of the work order and sterilization batch release record for the product involved found no indication that the implant dislocation was a result of a manufacturing or sterilization nonconformance.The eleos complaint history record was reviewed, which found seven (7) previous complaints for tibial hinge dislocation.Therefore, a complaint trend was not identified.The root cause of the tibial hinge dislocation could not be determined.Based upon review of the device history records and sterilization records, the investigation concluded that the root cause of the tibial hinge component is most likely not related to the design, manufacturing, and/or sterilization of the component.

• Brand Name: ELEOS
• Type of Device: TIBIAL POLY SPACER, 8MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17680529
• MDR Text Key: 322608039
• Report Number: 3013450937-2023-00190
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001208E0
• UDI-Public: B27825001208E0
• 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: 09/04/2023

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: 25001208E
• Device Catalogue Number: 25001208E
• Device Lot Number: 1921665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 08/06/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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: P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female