MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CEMENTED, 11 X 152MM, STRAIGHT, FLUTED, 25MM COLLAR

Model Number	25000011E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the loosening of the femoral stem was unable to be determined.The patient's medical history is unknown, and it is uncertain whether it contributed to this complaint.The patient's bone density is unknown, and it is uncertain whether it contributed to this complaint.The patient's weight is unknown, and it is uncertain whether it contributed to this complaint.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
Event or Problem Description
A (b)(6) female patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to a femoral stem loosening.The surgeon replaced the cemented segmental stem, two male-female midsections, a distal femur implant, a distal femur axial pin, and a tibial hinge component during the revision.The segmental stem that loosened was cemented with palancos bone cement during the primary eleos surgery.It is unknown what the patient's bone quality is.It is also unknown if the patient sustained a trauma prior to the failure.The patient's medical history is unknown.The patient's weight is unknown.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM, CEMENTED, 11 X 152MM, STRAIGHT, FLUTED, 25MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11335585
• Report Number: 3013450937-2021-00011
• Device Sequence Number: 19966447
• Product Code: KRO
• UDI-Device Identifier: B27825000011E0
• UDI-Public: B27825000011E0
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR