• 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 TIBIAL POLY SPACER, 8MM

  • 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 TIBIAL POLY SPACER, 8MM Back to Search Results
Model Number 25001208E
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Loss of Range of Motion (2032); Scarring (2061)
Event Date 03/11/2019
Event Type  Injury  
Manufacturer Narrative
The root cause for the patient developing scar tissue was unable to be determined. The patient has undergone two revision surgeries due to scar tissue developing around the patella. The patient's medical history is unknown. Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
 
Event Description
A (b)(6) year-old male patient underwent a revision surgery on (b)(6) 2019 performed by dr. (b)(6) due to scar tissue forming around the patient's patella which was causing pain, stiffness, and a loss of range of motion of the knee. The surgeon debrided the scar tissue and revised a distal femur component, a tibial poly spacer, a tibial hinge component, and a distal femur axial pin with identical implants.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameELEOS
Type of DeviceTIBIAL POLY SPACER, 8MM
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline road
arlington TN 38002
Manufacturer Contact
jonathan zachok
77 east halsey road
parsippany, NJ 07054
MDR Report Key10843728
MDR Text Key216363073
Report Number3013450937-2020-00173
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,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25001208E
Device Catalogue Number25001208E
Device Lot Number1714458
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
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: 11/16/2020 Patient Sequence Number: 1
-
-