MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS TIBIAL BLOCK AUGMENT

Model Number KTAGB115E

Device Problem Connection Problem (2900)

Patient Problem Joint Dislocation (2374)

Event Date 08/19/2020

Event Type  Injury  

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 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
• Type of Device: ELEOS TIBIAL BLOCK AUGMENT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 10510248
• MDR Text Key: 206292298
• Report Number: 3013450937-2020-00126
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KTAGB115E0
• UDI-Public: B278KTAGB115E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KTAGB115E
• Device Catalogue Number: KTAGB115E
• Device Lot Number: 1695421
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR