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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL RESURFACING FEMUR AXIAL PIN PROSTHESIS, KNEE

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ONKOS SURGICAL RESURFACING FEMUR AXIAL PIN PROSTHESIS, KNEE Back to Search Results
Catalog Number 25002112E
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Information (3190)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
This report is for one of two devices involved in this event, please refer to report 3013450937-2019-00023. The device history record and sterilization batch release record were reviewed and found that the design manufacturing and sterilization did not lead to this complaint. The component was disposed of and was unable to be further investigated. Should additional information be obtained the report will be supplemented.
 
Event Description
An eleos resurfacing femur limb salvage system was implanted and while assembling the components, the threads of the axial pin inserter/extractor fractured off within the resurfacing femur axial pin. The resurfacing femur axial pin was removed, and a new pin was placed.
 
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Brand NameRESURFACING FEMUR AXIAL PIN
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDIC
5677 airline road
arlington TN 38002
Manufacturer Contact
cristina butrico
77 east halsey road
parsippany, NJ 07054
9732645433
MDR Report Key8688677
MDR Text Key147651481
Report Number3013450937-2019-00022
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
Type of Report Initial,Followup
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number25002112E
Device Lot Number1764143
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2018
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: 06/11/2019 Patient Sequence Number: 1
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