• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ONKOS SURGICAL ELEOS SEGMENTAL STEM PROSTHESIS, KNEE Back to Search Results
Model Number FB-15152-03M
Device Problem Osseointegration Problem (3003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification. Also, the revised implant was unable to be obtained for further analysis. Should additional information be obtained the report will be supplemented.
 
Event Description
The surgeon was unable to get a good fit with the segmental stem intraoperatively and a larger stem was placed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameELEOS SEGMENTAL STEM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany, nj
Manufacturer (Section G)
PHILLIPS PRECISION INC.
7 paul kohner place
elmwood park, nj
Manufacturer Contact
cristina butrico
77 east halsey road
parsippany, nj 
2645433
MDR Report Key9918334
MDR Text Key186402525
Report Number3013450937-2020-00050
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 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFB-15152-03M
Device Catalogue NumberFB-15152-03M
Device Lot Number82295
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2019
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: 04/02/2020 Patient Sequence Number: 1
-
-