MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS SEGMENTAL STEM

Model Number	KSC18100E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the dissociation of the resurfacing femur and the stem extension was unable to be determined.The patient has undergone two previous revision surgeries for dissociation since her primary surgery all performed by dr.Siegel.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.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 of the implants, or a nonconformance.
Event or Problem Description
On (b)(6) 2020, a (b)(6)-year-old female underwent a revision surgery due to dissociation of stem extension and resurfacing femur dissociated.During the revision surgery, the tibial hinge component, tibial poly spacer, resurfacing femur, and resurfacing femur axial pin were all replaced with identical implants.

• Brand Name: ELEOS
• Common Device Name: ELEOS SEGMENTAL STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10631451
• Report Number: 3013450937-2020-00135
• Device Sequence Number: 3529454
• Product Code: KRO
• UDI-Device Identifier: B278KSC18100E0
• UDI-Public: B278KSC18100E0
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2026
• Device Model Number: KSC18100E
• Device Catalogue Number: KSC18100E
• Device Lot Number: 1750157
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2020
• 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: 46 YR