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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS MALE-FEMALE MIDSECTION PROSTHESIS, KNEE

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ONKOS SURGICAL ELEOS MALE-FEMALE MIDSECTION PROSTHESIS, KNEE Back to Search Results
Model Number 25001040E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2020
Event Type  malfunction  
Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification. It was requested that the sales representative obtain and return the alleged malfunctioned implant for further investigation. Should additional information be obtained the report will be supplemented.
 
Event Description
A midsection did not properly engage with the existing components during a revision surgery.
 
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Brand NameELEOS MALE-FEMALE MIDSECTION
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany, nj
Manufacturer (Section G)
MICROPORT ORTHOPEDIC
5677 airline road
arlington, tn
Manufacturer Contact
cristina butrico
77 east halsey road
parsippany, nj 
2645433
MDR Report Key9913176
MDR Text Key186184746
Report Number3013450937-2020-00048
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 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25001040E
Device Catalogue Number25001040E
Device Lot Number1813688
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/18/2019
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: 04/01/2020 Patient Sequence Number: 1
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