MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS TIBIAL BASEPLATE

Model Number	25002201E
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the dislocation of the tibial hinge component was unable to be determined.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 underwent a revision surgery of eleos components on (b)(6) 2020 performed by dr.(b)(6) due to the patient's tibial hinge component dislocating causing the lower leg to separate from the upper leg.The tibial augment that was placed during the primary surgery but was removed during the revision surgery and not replaced.A 20mm poly spacer was removed and replaced with an 8mm poly spacer.Bone was resected from the tibia and a 40mm midsection was placed.A 16mm x 100mm stem extension was removed and replaced with a 15mm x 100mm stem extension.The reason for the size change of the stem extension is not known.The segmental stem that was placed during the primary surgery was not explanted during the revision.The surgeon expected the implant during surgery and stated that it was not damaged.A distal femur axial pin, tibial hinge component, tibial baseplate, and distal femur components were explanted and replaced with identical components.

• Brand Name: ELEOS
• Common Device Name: ELEOS TIBIAL BASEPLATE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10510291
• Report Number: 3013450937-2020-00129
• Device Sequence Number: 2386073
• Product Code: KRO
• UDI-Device Identifier: B27825002201E0
• UDI-Public: B27825002201E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 25002201E
• Device Catalogue Number: 25002201E
• Device Lot Number: 1813678
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR