MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; RESURFACING FEMUR, SIZE: 3, LEFT

Model Number	2500L003E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2020
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 multiple revision surgeries for this problem with eleos and guardian components.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
A (b)(6) year old male patient underwent a revision surgery on (b)(6) 2020 performed by dr.(b)(6) due to dissociation of the resurfacing femur component and femoral stem extension component.During the revision, the surgeon replaced the resurfacing femur component, the resurfacing femur axial pin, and the stem extension component with a distal femur component, distal femur axial pin, and a segmental stem component respectively.The surgeon also replaced a tibial hinge component during the revision.

• Brand Name: ELEOS
• Common Device Name: RESURFACING FEMUR, SIZE: 3, LEFT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10659088
• Report Number: 3013450937-2020-00145
• Device Sequence Number: 3059280
• Product Code: KRO
• UDI-Device Identifier: B2782500L003E0
• UDI-Public: B2782500L003E0
• 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: 2020
• 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): 10/09/2020

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 Model Number: 2500L003E
• Device Catalogue Number: 2500L003E
• Device Lot Number: 1821817
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2020
• 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: 63 YR