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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE, SIZE 2
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ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE, SIZE 2 Back to Search Results
Model Number TB-2202E-01M
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)
Event Date 10/31/2021
Event Type  Injury  
Event Description
It was reported that the patient developed an alleged wound infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery: distal femur, male-female midsection, cemented stem extension, tibial baseplate, and cemented segmental stem.The surgeon performed a washout.No additional information regarding this adverse event has been provided.
 
Manufacturer Narrative
The investigation is in process.Once the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs have been submitted for this adverse event: #3013450937-2021-00301, #3013450937-2021-00302, #3013450937-2021-00303, #3013450937-2021-00304, #3013450937-2021-00305, #3013450937-2021-00306, #3013450937-2021-00308.
 
Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged infection could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.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 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.
 
Event Description
It was reported that the patient developed an alleged wound infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery: distal femur, male-female midsection, cemented stem extension, tibial baseplate, and cemented segmental stem.The surgeon performed a washout.No additional information regarding this adverse event has been provided.
 
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Brand Name
ELEOS
Type of Device
TIBIAL BASEPLATE, SIZE 2
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
PHILLIPS PRECISION INC
7 paul kohner pl
elmwood park NJ 07407
Manufacturer Contact
sara dailey
77 east halsey road
parsippany, NJ 07054
MDR Report Key12865355
MDR Text Key285703998
Report Number3013450937-2021-00307
Device Sequence Number1
Product Code KRO
UDI-Device IdentifierB278TB2202E01M0
UDI-PublicB278TB2202E01M0
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 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTB-2202E-01M
Device Catalogue NumberTB-2202E-01M
Device Lot Number90124-005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2021
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 25000009E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N CS-15120-03M, ELEOS CEMENTED SEGMENTAL STEM; P/N KSC01265E, ELEOS CEMENTED STEM EXTENSION; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age89 YR
Patient SexFemale
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