MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT WITH ROTATIONAL STOP

Model Number	25002100E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the post broke off of the patient's tibial hinge component.The surgeon performed a revision surgery on this patient on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, tibial poly spacer, and distal femur axial pin.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the implant fracture could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.
Event or Problem Description
It was reported that the post broke off of the patient's tibial hinge component.The surgeon performed a revision surgery on this patient on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, tibial poly spacer, and distal femur axial pin.No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Common Device Name: TIBIAL HINGE COMPONENT WITH ROTATIONAL STOP
• 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: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 13014833
• Report Number: 3013450937-2021-00328
• Device Sequence Number: 4911783
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: +B27825002100E0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2025
• Device Model Number: 25002100E
• Device Catalogue Number: 25002100E
• Device Lot Number: 1711270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000001E, ELEOS PROXIMAL FEMUR; P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25000051E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001060E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001140E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002203E, ELEOS TIBIAL BASEPLATE; P/N 26012802E, ELEOS FEMORAL HEAD; P/N KSC14100E, ELEOS CEMENTED STEM EXTENSION
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male