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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS SEGMENTAL STEM; PROSTHESIS, KNEE Back to Search Results
Model Number 2500BP14E
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code No Information (3190)
Date of Event 01/29/2019
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 segmental stem loosening.
 
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Brand Name
ELEOS SEGMENTAL STEM
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key8373716
Report Number3013450937-2019-00007
Device Sequence Number2197729
Product Code KRO
UDI-Device IdentifierB2782500BP14E0
UDI-PublicB2782500BP14E0
Combination Product (Y/N)N
Initial Reporter StateIN
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 company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/27/2019
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 Date04/10/2026
Device Model Number2500BP14E
Device Catalogue Number2500BP14E
Device Lot Number1750318
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/29/2019
Initial Report FDA Received Date02/27/2019
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 Age38 YR
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