MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; DISTAL FEMUR, LEFT, SEGMENTAL

Model Number 25000007E

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: 3013450937-2022-00168.

Event Description

It was reported that the patient fell for an unknown reason and the distal femur dissociated from the canal-filling segmental stem.The patient underwent a revision surgery on (b)(6) 2022 where the following implants were revised: distal femur, distal femur axial pin, tibial hinge component, poly spacer, and proximal tibia.No additional information regarding this event have been provided.

Event Description

It was reported that the patient fell for an unknown reason and the distal femur dissociated from the canal-filling segmental stem.The patient underwent a revision surgery on (b)(6) 2022 where the following implants were revised: distal femur, distal femur axial pin, tibial hinge component, poly spacer, and proximal tibia.No additional information regarding this event have been provided.

Manufacturer Narrative

This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.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: h3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4109: historical data 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 3331: analysis of production records.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.

• Brand Name: ELEOS
• Type of Device: DISTAL FEMUR, LEFT, SEGMENTAL
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 14466029
• MDR Text Key: 292521795
• Report Number: 3013450937-2022-00167
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825000007E0
• UDI-Public: B27825000007E0
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25000007E
• Device Catalogue Number: 25000007E
• Device Lot Number: 1885112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 25001208E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N FS-11120-03M, ELEOS CANAL-FILLING STEM; P/N FS-15120-03M, ELEOS CANAL-FILLING STEM; P/N PT-20000-02M, ELEOS PROXIMAL TIBIA; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male