MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING SEGMENTAL STEM, 12X120MM STRAIGHT SPLINED FULL PLASMA 25MM COLLAR

Model Number 2500SP12E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Insufficient Information (4580)

Event Date 10/21/2021

Event Type  Injury  

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's canal filling segmental stem loosened.A revision surgery was scheduled for the patient on (b)(6) 2021 but was cancelled due to the patient's potassium levels being too high.The revision surgery has not yet been rescheduled.No additional information regarding this adverse event has been provided.

Manufacturer Narrative

This report is being submitted to include corrected and additional information.The investigation is in process.The device is not expected to be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.The following sections have been updated: b2: outcomes attributed to this adverse event updated b4: date of report added b5: event description updated b7: other relevant history added d6b: explanted date added g3: date received by manufacturer added g6: type of report added h2: follow up type added h6: clinical code updated to 1848: fall h6: clinical code updated to 1870: bone fracture(s) h6: impact code updated to 4607: hospitalization or prolonged hospitalization h6: impact code updated to 4629: device revision or replacement h6: impact code updated to 4625: additional surgery h6: impact code updated to 4642: additional device required h6: impact code updated to 4624: surgical intervention h6: medical device problem code updated to 2993: adverse event without identified device or use problem h10: additional narratives/data.

Event Description

It was reported that the patient's fell and fractured their femur around the femoral stem.The patient had a revision surgery scheduled on (b)(6) 2021 but it was cancelled due to the patient's potassium levels being too high.The revision surgery was rescheduled to (b)(6) 2021.During the revision surgery, the following eleos implants were revised: distal femur, segmental stem, distal femur axial pin, tibial hinge component, and poly spacer.No additional information regarding this adverse 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 patient's peri-prosthetic 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: 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.

Event Description

It was reported that the patient's fell and fractured their femur around the femoral stem.The patient had a revision surgery scheduled on (b)(6) 2021 but it was cancelled due to the patient's potassium levels being too high.The revision surgery was rescheduled to (b)(6) 2021.During the revision surgery, the following eleos implants were revised: distal femur, segmental stem, distal femur axial pin, tibial hinge component, and poly spacer.No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Type of Device: CANAL-FILLING SEGMENTAL STEM, 12X120MM STRAIGHT SPLINED FULL PLASMA 25MM COLLAR
• 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: 12823939
• MDR Text Key: 280932962
• Report Number: 3013450937-2021-00280
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B2782500SP12E0
• UDI-Public: +B2782500SP12E0
• 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,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2500SP12E
• Device Catalogue Number: 2500SP12E
• Device Lot Number: 1768947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• 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 25001210E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002201E, ELEOS TIBIAL BASEPLATE; P/N KSC01265E, ELEOS STEM EXTENSION; P/N KTAGB110E, ELEOS TIBIAL BLOCK AUGMENT; P/N KTAGB110E, ELEOS TIBIAL BLOCK AUGMENT; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female