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

Model Number 25001208E

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported that the patient was experiencing knee locking.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, it was found that the post of the tibial poly spacer had broken off from the rest of the poly spacer.During the revision surgery, the surgeon revised the tibial poly spacer, male-female midsection, distal femur axial pin, tibial hinge component, and distal femur.No additional information regarding this adverse event has been received.

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.

Event Description

It was reported that the patient was experiencing knee locking.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, it was found that the post of the tibial poly spacer had broken off from the rest of the poly spacer.During the revision surgery, the surgeon revised the tibial poly spacer, male-female midsection, distal femur axial pin, tibial hinge component, and distal femur.No additional information regarding this adverse event has been received.

Manufacturer Narrative

This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation, however, an image of the explanted device was provided that showed that the post was broken offf of the tibial poly spacer.The root cause of the implant fracture could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added g3: date received by manufacturer added g6: type of report added h2: follow-up type added h3: device evaluated by manufacturer updated to no h6: type of investigation code updated to 3331: analysis of production records h6: type of investigation code updated to 4111: communication/interviews h6: type of investigation code updated to 4110: trend analysis h6: type of investigation code updated to 4114: device not returned h6: type of investigation code updated to 4117: device not accessible for testing h6: type of investigation code updated to 4109: historical data analysis h6: investigation findings code updated to 3252: fracture problem h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.

• 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: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 15002688
• MDR Text Key: 295803681
• Report Number: 3013450937-2022-00201
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25001208E
• Device Catalogue Number: 25001208E
• Device Lot Number: 1751055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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 25000007E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25002101E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male