FDA.reportPublic FDA data

MAUDE MDR 9878850

MDR report key
9878850
Report number
3013450937-2020-00045
Event key
0
Event type
3
Date of event
2020-02-25
Date received
2020-03-25
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 TIBIAL POLY SPACERPROSTHESIS, KNEEONKOS SURGICALKRO25001208E25001208E1699786R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2501. R

Event Narratives#

N

Patient 1

THIS REPORT IS FOR ONE OF SEVEN DEVICES INVOLVED IN THIS EVENT, PLEASE REFER TO REPORT 3013450937-2020-00039, 3013450937-2020-00040, 3013450937-2020-00041, 3013450937-2020-00042, 3013450937-2020-00043, AND 3013450937-2020-00044. 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

PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. THE SALES REPRESENTATIVE, PRESENT DURING THE SURGERY, RELAYED THAT UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE FEMORAL AND TIBIAL IMPLANTS HAD LOOSENED.