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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 25001212E
Device Problem Device Damaged by Another Device (2915)
Patient Problems Pain (1994); No Information (3190)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
This report is for one of two devices involved in this event, please refer to report 3013450937-2019-00048. The device history record and sterilization batch release record were reviewed and indicated that the component met specification. The tibial poly spacer was returned for further analysis and this report will be supplemented when further information is made available.
 
Event Description
Patient x-rays revealed that the post of the tibial hinge component had fractured and required surgical intervention. During the revision surgery, the tibial poly spacer was identified as being damaged and was revised.
 
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Brand NameELEOS TIBIAL POLY SPACER
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDIC
5677 airline road
arlington TN 38002
Manufacturer Contact
cristina butrico
77 east halsey road
parsippany, NJ 07054
9732645433
MDR Report Key9072571
MDR Text Key160615391
Report Number3013450937-2019-00055
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 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25001212E
Device Catalogue Number25001212E
Device Lot Number1699710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2017
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: 09/16/2019 Patient Sequence Number: 1
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