MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CEMENTED, STRAIGHT, 15X120MM 32MM COLLAR

Model Number CS-15120-03M

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Little information is known about this complaint.Once more information is obtained, a supplemental report will be submitted.

Event Description

A patient underwent a revision surgery due to unknown reasons.The patient eleos distal femur components in place but they were revised with eleos total femur implants.When more information is known, a supplement report will be submitted.

Manufacturer Narrative

The root cause for the patient's stem loosening was unable to be definitively determined.The patient's medical history and bone quality is unknown.It is unknown if there were any external factors, such as a traumatic injury, which may have contributed to this complaint.However, 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 Description

A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to loosening of the patient's femoral stem.There was no report of an associated infection.The patient had an eleos distal femur system placed during his original eleos surgery which took place on (b)(6) 2021.The surgeon explanted the loosened stem and explanted the patient's remaining femur and placed a male-female midsection, a male-male midsection, and a proximal femur component.A femoral head was placed but this was not an eleos component.

• Brand Name: ELEOS
• Type of Device: SEGMENTAL STEM, CEMENTED, STRAIGHT, 15X120MM 32MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12070678
• MDR Text Key: 258601669
• Report Number: 3013450937-2021-00124
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/18/2024
• Device Model Number: CS-15120-03M
• Device Lot Number: 81680
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR