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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM CANAL FILLING PROSTHESIS, KNEE

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ONKOS SURGICAL ELEOS SEGMENTAL STEM CANAL FILLING PROSTHESIS, KNEE Back to Search Results
Model Number 2500SP16E
Device Problem Failure to Osseointegrate (1863)
Patient Problem Failure of Implant (1924)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification. Should additional information be obtained the report will be supplemented.
 
Event Description
Patient underwent a revision surgery due to the distal femoral stem subsided within the intramedullary canal.
 
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Brand NameELEOS SEGMENTAL STEM CANAL FILLING
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 Key8233469
MDR Text Key132597771
Report Number3013450937-2019-00006
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
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2500SP16E
Device Catalogue Number2500SP16E
Device Lot Number1717072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/19/2017
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: 01/10/2019 Patient Sequence Number: 1
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