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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM CANAL FILLING; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS SEGMENTAL STEM CANAL FILLING; PROSTHESIS, KNEE Back to Search Results
Model Number 2500SP16E
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/10/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 underwent a revision surgery due to the distal femoral stem subsided within the intramedullary canal.
 
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Brand Name
ELEOS SEGMENTAL STEM CANAL FILLING
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key8233469
Report Number3013450937-2019-00006
Device Sequence Number216788
Product Code KRO
UDI-Device IdentifierB2782500SP16E0
UDI-PublicB2782500SP16E0
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 Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/09/2019
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 Date07/19/2025
Device Model Number2500SP16E
Device Catalogue Number2500SP16E
Device Lot Number1717072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/10/2018
Initial Report FDA Received Date01/10/2019
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 Age71 YR
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