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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, 15X120MM 32MM COLLAR

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ONKOS SURGICAL ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, 15X120MM 32MM COLLAR Back to Search Results
Model Number CS-15120-03M
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  Injury  
Manufacturer Narrative
Little information is known about this complaint. Once more information is obtained, a supplemental report will be submitted.
 
Event Description
A patient underwent a revision surgery due to unknown reasons. The patient eleos distal femur components in place but they were revised with eleos total femur implants. When more information is known, a supplement report will be submitted.
 
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Brand NameELEOS
Type of DeviceSEGMENTAL STEM, CEMENTED, STRAIGHT, 15X120MM 32MM COLLAR
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
PHILLIPS PRECISION INC.
7 paul kohner pl
elmwood park NJ 07407
Manufacturer Contact
jonathan zachok
77 east halsey road
parsippany, NJ 07054
MDR Report Key12070678
MDR Text Key258601669
Report Number3013450937-2021-00124
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCS-15120-03M
Device Lot Number81680
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/25/2021 Patient Sequence Number: 1
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