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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM PROXIMAL TIBIA WITH BIOGRIP

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ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM PROXIMAL TIBIA WITH BIOGRIP Back to Search Results
Model Number PT-20000-02M
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 02/22/2022
Event Type  Injury  
Manufacturer Narrative
No additional information is available at this time. Once additional information is received, this record will be updated accordingly.
 
Event Description
It was reported that a patient underwent revision surgery on (b)(6) 2022 due to suture tearing post-operatively. The tibial tubercle was no longer attached to the eleos proximal tibia implant, causing the patient to experience anterior knee pain. During the revision procedure, the eleos tibial polyspacer, eleos tibial hinge, eleos resurfacing femur axial pin, and eleos proximal tibia were replaced. No specific device failures related to an onkos implant were reported. However, this event will be reported as a serious injury due to revision procedure. This record captures the eleos proximal tibia.
 
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Brand NameELEOS LIMB SALVAGE SYSTEM
Type of DevicePROXIMAL TIBIA WITH BIOGRIP
Manufacturer (Section D)
ONKOS SURGICAL
77 e halsey rd
parsippany NJ 07054
Manufacturer (Section G)
PHILLIPS PRECISION INC
7 paul kohner pl
elmwood park NJ 07407
Manufacturer Contact
upasana basnet
77 e halsey rd
parsippany, NJ 07054
MDR Report Key13840377
MDR Text Key287549831
Report Number3013450937-2022-00117
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203090
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
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPT-20000-02M
Device Catalogue NumberPT-20000-02M
Device Lot Number88658RR-002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2021
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: 03/21/2022 Patient Sequence Number: 1
Treatment
ELEOS CANAL FILLING STEM, P/N FS-14120-03M; ELEOS RESURFACING FEMUR AXIAL PIN, P/N 25002113E; ELEOS RESURFACING FEMUR, P/N 250L003E; ELEOS STEM EXTENSION, P/N KSP13140E; ELEOS TIBIAL HINGE, P/N THSMWRS01M; ELEOS TIBIAL POLYSPACER, P/N 25001208E
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