MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STRAIGHT SEGMENTAL STEM, 11X152MM

Model Number	25000011E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
It was reported that the patient's femoral 11x152mm bowed segmental stem fractured.The patient was admitted to the emergency room on (b)(6) 2022.The patient was revised on (b)(6) 2022 and the following implants were revised: two male-female midsections, and segmental stem.No additional informatioin regarding this adverse event has been reported.
Additional Manufacturer Narrative
This report is being submitted to include additional and corrected information.The investigation is complete.The device was not returned for evaluation.The root cause of the implant fracture could not be determined.The device history records and sterilization batch records were reviewed which did not indicate any deviations that could have contributed to this complaint.Multiple attempts were made to obtain additional information.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 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 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.
Event or Problem Description
It was reported that the patient's femoral 11x152mm cemented straight segmental stem fractured.The patient was admitted to the emergency room on (b)(6) 2022.The patient was revised on (b)(6) 2022 and the following implants were revised: two male-female midsections, and segmental stem.It is unknown if the patient endured any trauma.Multiple attempts have been made for additional information.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STRAIGHT SEGMENTAL STEM, 11X152MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: sara dailey ; 5677 airline road; arlington, TN 38002
• MDR Report Key: 15655116
• Report Number: 3013450937-2022-00303
• Device Sequence Number: 12253841
• Product Code: KRO
• UDI-Device Identifier: B27825000011E0
• UDI-Public: B27825000011E0
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2025
• Device Model Number: 25000011E
• Device Catalogue Number: 25000011E
• Device Lot Number: 1699437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001070E, ELEOS MALE FEMALE MIDSECTION; P/N 25001110E, ELEOS MALE FEMALE MIDSECTION; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 22 YR
• Patient Sex: Female