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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS RESURFACING FEMUR, SIZE 2, RIGHT

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ONKOS SURGICAL ELEOS RESURFACING FEMUR, SIZE 2, RIGHT Back to Search Results
Model Number 2500R002E
Device Problem Break (1069)
Patient Problem Joint Laxity (4526)
Event Date 12/16/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is in process. The device is expected to be returned for evaluation. When the investigation is complete, a supplemental mdr will be submitted accordingly. Multiple mdr reports were submitted for this event: #3013450937-2022-00002.
 
Event Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021. The patient presented with varus/valgus instability. During the revision surgery, it was observed that the stem extension dissociated from the resurfacing femur. It was observed that the boss of the resurfacing femur was cracked. The surgeon debrided the wound and explanted the following implants: poly spacer, resurfacing femur, tibial hinge component, resurfacing femur axial pin, and stem extension. The surgeon placed a distal femoral replacement system. No additional information regarding this adverse event has been reported.
 
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Brand NameELEOS
Type of DeviceRESURFACING FEMUR, SIZE 2, RIGHT
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline road
arlington TN 38002
Manufacturer Contact
sara dailey
77 east halsey road
parsippany, NJ 07054
MDR Report Key13168650
MDR Text Key283254049
Report Number3013450937-2022-00001
Device Sequence Number1
Product Code KRO
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 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2500R002E
Device Catalogue Number2500R002E
Device Lot Number1731796
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2017
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: 01/05/2022 Patient Sequence Number: 1
Treatment
P/N 25001220E, ELEOS TIBIAL POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002112E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N KSP10140E, ELEOS CANAL-FILLING STEM EXTENSION
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