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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL POLY SPACER; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS TIBIAL POLY SPACER; PROSTHESIS, KNEE Back to Search Results
Model Number 25001220E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/09/2020
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 3013450937-2020-00170 and 3013450937-2020-00177.The device history records and sterilization batch release records 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 TIBIAL POLY SPACER
Common Device Name
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 e halsey road
parsippany NJ 07054
MDR Report Key10870055
Report Number3013450937-2020-00176
Device Sequence Number16957508
Product Code KRO
UDI-Device IdentifierB27825001220E0
UDI-PublicB27825001220E0
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K161520
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
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) 11/06/2020
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 Date03/07/2025
Device Model Number25001220E
Device Catalogue Number25001220E
Device Lot Number1699712
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/09/2020
Initial Report FDA Received Date11/19/2020
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;
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