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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS DISTAL FEMUR PROSTHESIS, KNEE

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ONKOS SURGICAL ELEOS DISTAL FEMUR PROSTHESIS, KNEE Back to Search Results
Model Number 25000007E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification. The component was unable to be obtained for further analysis. Should additional information be obtained the report will be supplemented.
 
Event Description
Patient was experiencing pain and surgical intervention was required to revise implants.
 
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Brand NameELEOS DISTAL FEMUR
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 e halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS, INC.
5677 airline road
arlington TN 38002
Manufacturer Contact
cristina butrico
77 e halsey road
parsippany, NJ 07054
MDR Report Key11088101
MDR Text Key228177774
Report Number3013450937-2020-00191
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 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25000007E
Device Catalogue Number25000007E
Device Lot Number1778819
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2019
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: 12/29/2020 Patient Sequence Number: 1
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