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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS RESURFACING FEMUR AXIAL PIN; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS RESURFACING FEMUR AXIAL PIN; PROSTHESIS, KNEE Back to Search Results
Model Number 25002112E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/08/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is for one of three devices involved in the event, please refer to report 3013450937-2021-00016 and 3013450937-2021-00017.The device history record and sterilization batch release record were reviewed and indicated that all components involved met specification.It was relayed by the sales representative that the explanted components had been disposed of at the hospital.Should additional information be obtained the report will be supplemented.
 
Event or Problem Description
Patient underwent a revision surgery due to an alleged infection.
 
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Brand Name
ELEOS RESURFACING FEMUR AXIAL PIN
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 e halsey road
parsippany NJ 07054
MDR Report Key11478380
Report Number3013450937-2021-00018
Device Sequence Number3625480
Product Code KRO
UDI-Device IdentifierB27825002112E0
UDI-PublicB27825002112E0
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K161520
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/12/2021
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 Model Number25002112E
Device Catalogue Number25002112E
Device Lot Number1807958
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2021
Initial Report FDA Received Date03/12/2021
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 Age70 YR
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