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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT, W/O ROTATIONAL STOP
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ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT, W/O ROTATIONAL STOP Back to Search Results
Model Number 25002101E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
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) 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.
 
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.The complaint was reported to onkos on (b)(6) 2020.
 
Event Description
A 39-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.
 
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Brand Name
ELEOS
Type of Device
TIBIAL HINGE COMPONENT, W/O ROTATIONAL STOP
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key10843770
MDR Text Key216375170
Report Number3013450937-2020-00174
Device Sequence Number1
Product Code KRO
UDI-Device IdentifierB27825002101E0
UDI-PublicB27825002101E0
Combination Product (y/n)N
PMA/PMN Number
K161520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
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 Health Professional
Device Model Number25002101E
Device Catalogue Number25002101E
Device Lot Number1711285
Date Manufacturer Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
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