Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 40MM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 40MM Back to Search Results
Model Number 25001040E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)
Event Date 10/04/2021
Event Type  Injury  
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: #3013450937-2021-00237, #3013450937-2021-00239, #3013450937-2021-00240, #3013450937-2021-00241, #3013450937-2021-00242, #3013450937-2021-00243, #3013450937-2021-00244, #3013450937-2021-00245.
 
Event Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient's knee was discharging fluid and the surgeon wanted to test for an infection.During the revision surgery, the surgeon performed a poly swap and a washout.The following eleos implants were revised during the revision surgery: 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 segmental stem, tibial baseplate, cemented stem extension, and resurfacing patella.No additional information regarding this event has been provided.
 
Event Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient's knee was discharging fluid and the surgeon wanted to test for an infection.During the revision surgery, the surgeon performed a poly swap and a washout.The following eleos implants were revised during the revision surgery: 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 segmental stem, tibial baseplate, cemented stem extension, and resurfacing patella.No additional information regarding this event has been provided.
 
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: 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELEOS
Type of Device
MALE-FEMALE MIDSECTION, 40MM
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
MDR Report Key12712523
MDR Text Key278817725
Report Number3013450937-2021-00238
Device Sequence Number1
Product Code KRO
UDI-Device IdentifierB27825001040E0
UDI-Public+B27825001040E0
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 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number25001040E
Device Catalogue Number25001040E
Device Lot Number1882071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2021
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 25001208E. ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002202E, ELEOS TIBIAL BASEPLATE; P/N CS-11120-03M, ELEOS CEMENTED SEGMENTAL STEM; P/N KPONTP32E, ELEOS RESURFACING PATELLA; P/N KSC01530E, ELEOS CEMENTED STEM EXTENSION; P/N THSMWOS01M, ELEOS TIBIAL HINGE COMPONENT; P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001208E. ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002202E, ELEOS TIBIAL BASEPLATE; P/N CS-11120-03M, ELEOS CEMENTED SEGMENTAL STEM; P/N KPONTP32E, ELEOS RESURFACING PATELLA; P/N KSC01530E, ELEOS CEMENTED STEM EXTENSION; P/N THSMWOS01M, ELEOS TIBIAL HINGE COMPONENT
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age87 YR
Patient SexFemale
-
-