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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.
 
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Brand NameELEOS TIBIAL POLY SPACER 10MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline road
arlington TN 38002
Manufacturer Contact
jackie dahlmeier
77 east halsey road
parsippany, NJ 07054
9732645430
MDR Report Key7609749
MDR Text Key111340797
Report Number3013450937-2018-00012
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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
Device Model Number25001210E
Device Catalogue Number25001210E
Device Lot Number1699787
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/18/2018 Patient Sequence Number: 1
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