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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 25000011E
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Date of Event 03/24/2020
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.The sales representative indicated that the original eleos stem was undersized and possibly had a poor cement mantle, which could have contributed to the stem loosening.The component was unable to be obtained for further analysis because they were disposed of after surgery.Should additional information be obtained the report will be supplemented.
 
Event or Problem Description
Patient underwent a revision surgery due to the femoral 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
MDR Report Key9987666
Report Number3013450937-2020-00053
Device Sequence Number17292428
Product Code KRO
UDI-Device IdentifierB27825000011E0
UDI-PublicB27825000011E0
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 Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/22/2020
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 Date03/11/2025
Device Model Number25000011E
Device Catalogue Number25000011E
Device Lot Number1695371
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/24/2020
Initial Report FDA Received Date04/22/2020
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;
Patient Age77 YR
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