MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CEMENTED, 12X100MM, STRAIGHT, FLUTED

Model Number KSC12100E

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Contracture (4528)

Event Date 02/04/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery on (b)(6) 2022 due to their stem extension loosening and a flexion contracture.The following eleos implants were revised: tibial hinge component, tibial poly spacer, resurfacing femur, resurfacing femur axial pin, and stem extension.No additional information regarding this event has been provided.

Manufacturer Narrative

The investigation is in process.The device will not be returned.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: 3013450937-2022-00113, 3013450937-2022-00114, 3013450937-2022-00115,and 3013450937-2022-00116.

Event Description

It was reported that the patient underwent a revision surgery on 04 february 2022 due to their stem extension loosening and a flexion contracture.The following eleos implants were revised: tibial hinge component, tibial poly spacer, resurfacing femur, resurfacing femur axial pin, and stem extension.No additional information regarding this event has 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 root cause of the adverse event 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 213: no device problem found; h6: investigation conclusions code updated to 4315: cause not established; h10: additional narratives/data.

• Brand Name: ELEOS
• Type of Device: STEM EXTENSION, CEMENTED, 12X100MM, STRAIGHT, FLUTED
• 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: 13675008
• MDR Text Key: 286640745
• Report Number: 3013450937-2022-00112
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSC12100E0
• UDI-Public: B278KSC12100E0
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSC12100E
• Device Catalogue Number: KSC12100E
• Device Lot Number: 1711583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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 TIBIAL POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002112E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N 25002201E, ELEOS TIBIAL BASEPLATE; P/N 2500L002E, ELEOS RESURFACING FEMUR; P/N KSC01465E, ELEOS CEMENTED STEM EXTENSION
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female