FDA.reportPublic FDA data

MAUDE MDR 1618575

MDR report key
1618575
Report number
9613369-2010-00011
Event key
0
Event type
3
Date of event
2010-01-29
Date received
2010-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MRS. LEAH EASLEY
Address
1450 BROOKS RD. MEMPHIS TN 38116 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NISAWBLADE/EKDSMITH & NEPHEW, INC. AG ORTHOPAEDIC DIVISIONEKDNANINIR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-02-2601. H

Event Narratives#

D

Patient 1

IT HAS BEEN REPORTED THAT SURGERY TIME WAS EXTENDED BECAUSE THE SAWBLADES WOULD NOT FIT THROUGH THE CUTTING BLOCKS CORRECTLY. THE SURGEON ELECTED TO CONTINUE WITH THE SURGERY, AND ONCE THE SURGICAL PROCEDURE WAS COMPLETED, THE UNICONDYLAR KNEE COMPONENTS DID NOT TRACK CORRECTLY. AT THAT TIME THE SURGEON ELECTED TO CHANGE FROM THE UNICONDYLAR KNEE TO A TOTAL KNEE.

N

Patient 1

NA