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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS STEM EXTENSION; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS STEM EXTENSION; PROSTHESIS, KNEE Back to Search Results
Model Number KSC12100E
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is for one of two devices involved in this event, please refer to report: 3013450937-2020-00075.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
Patient underwent a revision surgery due to the resurfacing femur and stem extension dissociating.
 
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Brand Name
ELEOS STEM EXTENSION
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany, nj
MDR Report Key10059059
Report Number3013450937-2020-00076
Device Sequence Number2848659
Product Code KRO
UDI-Device IdentifierB278KSC12100E0
UDI-PublicB278KSC12100E0
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K161520
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/14/2020
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 Date03/21/2025
Device Model NumberKSC12100E
Device Catalogue NumberKSC12100E
Device Lot Number1697272
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/17/2020
Initial Report FDA Received Date05/14/2020
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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