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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS RESURFACING FEMUR; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS RESURFACING FEMUR; PROSTHESIS, KNEE Back to Search Results
Model Number 2500R002E
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/21/2019
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 3013450937-2020-00029.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
The patient underwent a revision surgery due to knee pain and upon intraoperative inspection it was identified that the femur and stem had loosened.
 
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Brand Name
ELEOS RESURFACING FEMUR
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany, nj
MDR Report Key9813776
Report Number3013450937-2020-00028
Device Sequence Number1551599
Product Code KRO
UDI-Device IdentifierB2782500R002E0
UDI-PublicB2782500R002E0
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 company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/10/2020
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 Date03/17/2025
Device Model Number2500R002E
Device Catalogue Number2500R002E
Device Lot Number1700341
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2020
Initial Report FDA Received Date03/10/2020
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 Age56 YR
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