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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS TIBIAL BASEPLATE SIZE 3
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ONKOS SURGICAL ELEOS; ELEOS TIBIAL BASEPLATE SIZE 3 Back to Search Results
Model Number 25002203E
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 01/04/2022
Event Type  Injury  
Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this adverse event: 3013450937-2022-000031, 3013450937-2022-000032, 3013450937-2022-000033, 3013450937-2022-000034, 3013450937-2022-000036, 3013450937-2022-000037 and 3013450937-2022-000038.
 
Event Description
It was reported that the patient scheduled a revision surgery on (b)(6) 2022 for a poly swap after having a distal femoral replacement surgery on (b)(6) 2021.The revision surgery was cancelled and has not been rescheduled.It was cancelled due to alleged patient illness.No additional information regarding this adverse event has been provided.
 
Manufacturer Narrative
It was reported on 04 january 2022 that a patient was scheduled to undergo a revision procedure to replace the eleos poly spacer component.The patient's primary surgery date was (b)(6) 2021.The following implants remain implanted in the patient: distal femur, distal femur axial pin, cemented stem, cemented stem extension, male-female midsection, tibial baseplate, tibial hinge, and tibial poly spacer.The revision procedure was cancelled due to alleged patient illness.Patient's medical and previous surgical history was not available for review.Details regarding patient compliance, activity levels, and trauma were unknown as well.A review of the work orders and sterilization batch release records for the products involved found no indication that the adverse event was a result of a manufacturing or sterilization nonconformance.As additional information regarding the alleged patient illness was not provided, a root cause could not be determined conclusively and it cannot be established whether an onkos device caused or contributed to the event.
 
Event Description
It was reported that the patient scheduled a revision surgery on (b)(6) 2022 for a poly swap after having a distal femoral replacement surgery on (b)(6) 2021.The revision surgery was cancelled and has not been rescheduled.It was cancelled due to alleged patient illness.No additional information regarding this adverse event has been provided.This record captures the tibial baseplate.
 
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Brand Name
ELEOS
Type of Device
ELEOS TIBIAL BASEPLATE SIZE 3
Manufacturer (Section D)
ONKOS SURGICAL
77 e halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline road
arlington TN 38002
Manufacturer Contact
upasana basnet
77 east halsey road
parsippany, NJ 07054
8447672766
MDR Report Key13447637
MDR Text Key285043045
Report Number3013450937-2022-00035
Device Sequence Number1
Product Code KRO
UDI-Device IdentifierB27825002203E0
UDI-PublicB27825002203E0
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 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number25002203E
Device Catalogue Number25002203E
Device Lot Number1826751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1841268 ELEOS STEM EXTENSION, CEMENTED; 1841268 ELEOS STEM EXTENSION, CEMENTED; 25000009E ELEOS DISTAL FEMUR; 25000009E ELEOS DISTAL FEMUR; 25001070E ELEOS MALE-FEMALE MIDSECTION; 25001070E ELEOS MALE-FEMALE MIDSECTION; 25001208E ELEOS TIBIAL POLY SPACER; 25001208E ELEOS TIBIAL POLY SPACER; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; CS-17120-03M ELEOS CEMENTED STEM; CS-17120-03M ELEOS CEMENTED STEM; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP
Patient Age82 YR
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