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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT
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ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT Back to Search Results
Model Number 25002100E
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Little information is known about this complaint.It is unknown why the surgery was performed or if a failure of the device contributed.When more information is made available, a supplement report will be submitted.
 
Event or Problem Description
A patient was reported to have undergone a revision surgery where a washout was performed.The reason for the washout is currently unknown.A postbilling form from the revision surgery found that a new tibial hinge component, tibial poly spacer, and a distal femur axial pin were placed.This was most likely the result of replacing explanted implants.It is unknown at this time whether a failure of these implants occured.
 
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Brand Name
ELEOS
Common Device Name
TIBIAL HINGE COMPONENT
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key11786328
Report Number3013450937-2021-00066
Device Sequence Number11677398
Product Code KRO
UDI-Device IdentifierB27825002100E0
UDI-PublicB27825002100E0
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K161520
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/06/2021
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 Model Number25002100E
Device Catalogue Number25002100E
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2021
Initial Report FDA Received Date05/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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