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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL POLY SPACER 10MM; PROSTHESIS, KNEE
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ONKOS SURGICAL ELEOS TIBIAL POLY SPACER 10MM; PROSTHESIS, KNEE Back to Search Results
Model Number 25001210E
Device Problems Disassembly (1168); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Migration (4003)
Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)
Event Date 05/22/2018
Event Type  Injury  
Manufacturer Narrative
This report is for one of two devices involved in the event, please refer to report 3013450937-2018-000011 for the other.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and patient x-rays were requested along with the explanted components.The tibial poly spacer had been returned for further analysis and all other components involved were not revised.This investigation is currently ongoing and should additional information be obtained the report will be supplemented.
 
Event Description
The patient presented with a dislocated hinge component, which required surgical intervention.During the revision surgery it was found that the tibial poly spacer disengaged and migrated to the surface of the knee.
 
Manufacturer Narrative
This report is for one of two devices involved in the event, please refer to report 3013450937-2018-00011 for the other.Based upon the patient information, device history review, and the returned product evaluation it can be concluded that the failure was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained, the complaint will be re-opened and the report will be supplemented.
 
Event Description
The patient presented with a dislocated hinge component, which required surgical intervention.During the revision surgery it was found that the tibial poly spacer disengaged and migrated to the surface of the knee.
 
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Brand Name
ELEOS TIBIAL POLY SPACER 10MM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key7609749
MDR Text Key111340797
Report Number3013450937-2018-00012
Device Sequence Number1
Product Code KRO
UDI-Device IdentifierB27825001210E0
UDI-PublicB27825001210E0
Combination Product (y/n)N
PMA/PMN Number
K161520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number25001210E
Device Catalogue Number25001210E
Device Lot Number1699787
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Was the Report Sent to FDA? No
Date Manufacturer Received05/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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