FDA.reportPublic FDA data

MAUDE MDR 9813782

MDR report key
9813782
Report number
3013450937-2020-00029
Event key
0
Event type
3
Date of event
2019-11-21
Date received
2020-03-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CRISTINA BUTRICO
Address
77 EAST HALSEY ROAD PARSIPPANY, NJ US
Phone
264-264-2645
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ELEOS STEM EXTENSIONPROSTHESIS, KNEEONKOS SURGICALKROKSP14100EKSP14100E1703575R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1001. R

Event Narratives#

N

Patient 1

THIS REPORT IS FOR ONE OF TWO DEVICES INVOLVED IN THIS EVENT, PLEASE REFER TO REPORT 3013450937-2020-00028. THE DEVICE HISTORY RECORD AND STERILIZATION BATCH RELEASE RECORD WERE REVIEWED AND INDICATED THAT THE COMPONENT INVOLVED MET SPECIFICATION. THE COMPONENT WAS UNABLE TO BE OBTAINED FOR FURTHER ANALYSIS. SHOULD ADDITIONAL INFORMATION BE OBTAINED THE REPORT WILL BE SUPPLEMENTED.

D

Patient 1

THE PATIENT UNDERWENT A REVISION SURGERY DUE TO KNEE PAIN AND UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE FEMUR AND STEM HAD LOOSENED.