FDA.reportPublic FDA data

MAUDE MDR 3323240

MDR report key
3323240
Report number
1020279-2013-00425
Event key
0
Event type
3
Date of event
2013-08-14
Date received
2013-09-03
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
MR PHILLIP EMMERT
Address
1450 E. 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
1OXINIUMOXINIUM FEM HD 12/14 32MM +0SMITH&NEPHEW, INCLPF7134320011CM13357* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-03713376521. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

N

Patient 1

.