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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS PROXIMAL TIBIA; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS PROXIMAL TIBIA; PROSTHESIS, KNEE Back to Search Results
Model Number 25002200E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/26/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This report is for one of five devices involved in this event, please refer to report 3013450937-2019-00069, 3013450937-2019-00070, 3013450937-2019-00071, and 3013450937-2019-00072.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.Should additional information be obtained the report will be supplemented.
 
Event or Problem Description
Patient presented with appreciable medio-lateral instability.
 
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Brand Name
ELEOS PROXIMAL TIBIA
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key9497789
Report Number3013450937-2019-00073
Device Sequence Number1305005
Product Code KRO
UDI-Device IdentifierB27825002200E0
UDI-PublicB27825002200E0
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K161520
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/19/2019
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 Date04/30/2026
Device Model Number25002200E
Device Catalogue Number25002200E
Device Lot Number1754108
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2019
Initial Report FDA Received Date12/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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