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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 16MM
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ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 16MM Back to Search Results
Model Number 25001216E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Date 04/05/2023
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to soft tissue laxity.During the revision surgery, the surgeon revised the distal femur axial pin, poly spacer, and tibial hinge component.The 16mm poly spacer was revised to a 20mm poly spacer.No additional information regarding this adverse event has been reported.
 
Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2023-00060, #3013450937-2023-00061.The following mdrs were submitted for the same patient: #3013450937-2021-00270, #3013450937-2021-00271, #3013450937-2021-00272, #3013450937-2021-00273, #3013450937-2021-00274, #3013450937-2021-00275, #3013450937-2021-00276, #3013450937-2021-00277, #3013450937-2021-00278, #3013450937-2021-00279.
 
Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and there were no non-conformances identified that would have contributed to this adverse event.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added g3: date received by manufacturer added g6: type of report added h2: follow-up type added h3: device evaluated by manufacturer updated to no h6: type of investigation code updated to 3331: analysis of production records h6: type of investigation code updated to 4109: historical data analysis h6: type of investigation code updated to 4110: trend analysis h6: type of investigation code updated to 4114: device not returned h6: investigation findings code updated to 3221: no findings available h6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
 
Event Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to soft tissue laxity.During the revision surgery, the surgeon revised the distal femur axial pin, poly spacer, and tibial hinge component.The 16mm poly spacer was revised to a 20mm poly spacer.No additional information regarding this adverse event has been reported.
 
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Brand Name
ELEOS
Type of Device
TIBIAL POLY SPACER, 16MM
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline rd
arlington TN 38002
Manufacturer Contact
sara dailey
77 east halsey road
parsippany, NJ 07054
8447672766
MDR Report Key16843961
MDR Text Key314285567
Report Number3013450937-2023-00062
Device Sequence Number1
Product Code KRO
UDI-Device IdentifierB27825001216E0
UDI-PublicB27825001216E0
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 06/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number25001216E
Device Catalogue Number25001216E
Device Lot Number1856900
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2020
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
P/N 25000007E, ELEOS DISTAL FEMUR.; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N 25002203E, ELEOS TIBIAL BASEPLATE.; P/N 2500BP22E, ELEOS SEGMENTAL STEM.; P/N KSP18140E, ELEOS STEM EXTENSION.; P/N KTAGB305E, ELEOS TIBIAL BLOCK AUGMENT.; P/N KTAGB315E, ELEOS TIBIAL BLOCK AUGMENT.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
Patient Outcome(s) Hospitalization;
Patient Age67 YR
Patient SexMale
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