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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS MALE-FEMALE MIDSECTION, 90MM

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ONKOS SURGICAL ELEOS MALE-FEMALE MIDSECTION, 90MM Back to Search Results
Model Number 25001090E
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Ulcer (2274)
Event Date 08/09/2021
Event Type  Injury  
Manufacturer Narrative
The root cause for the patient developing ulcers around the eleos implants was unable to be definitively determined. It was not reported that the surgeon believed that there was a malfunction of the implants. No information is known about the patient's medical history, and it is unknown if it may have contributed to this complaint. There were no indications that there was a nonconformance during manufacturing or sterilization which would have contributed to the complaint.
 
Event Description
A patient underwent a revision surgery on (b)(6) 2021 performed by dr. (b)(6). The surgery was performed due to ulceration around eleos total femur component. During the surgery, the surgeon removed all implants that were implanted at the time as it was decided that the patient's leg would be amputated above the knee. To give the patient's thigh structure, a male-female midsection with a custom end cap implant was placed in the patient's upper leg.
 
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Brand NameELEOS
Type of DeviceMALE-FEMALE MIDSECTION, 90MM
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
jonathan zachok
77 east halsey road
parsippany, NJ 07054
MDR Report Key12441350
MDR Text Key271719654
Report Number3013450937-2021-00191
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25001090E
Device Catalogue Number25001090E
Device Lot Number1807960
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2019
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: 09/08/2021 Patient Sequence Number: 1
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