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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL HINGE COMPONENT; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS TIBIAL HINGE COMPONENT; PROSTHESIS, KNEE Back to Search Results
Model Number 25002101E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Joint Swelling (2356)
Date of Event 10/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is for one of three devices involved in this event, please refer to report 3013450937-2019-00066 and 3013450937-2019-00067.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The component was unable to be obtained for further analysis.Should additional information be obtained the report will be supplemented.
 
Event or Problem Description
The patient underwent a revision surgery due to an alleged infection.
 
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Brand Name
ELEOS TIBIAL HINGE COMPONENT
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key9356282
Report Number3013450937-2019-00065
Device Sequence Number19392428
Product Code KRO
UDI-Device IdentifierB27825002101E0
UDI-PublicB27825002101E0
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K161520
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/21/2019
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 Date06/19/2026
Device Model Number25002101E
Device Catalogue Number25002101E
Device Lot Number1736498
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2019
Initial Report FDA Received Date11/21/2019
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;
Patient Age62 YR
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