FDA.reportPublic FDA data

MAUDE MDR 350379

MDR report key
350379
Report number
1043534-2001-00084
Event key
0
Event type
3
Date of event
2001-07-27
Date received
2001-09-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DEBBY DAURER
Address
5677 AIRLINE ROAD ARLINGTON TN 38002 US
Phone
901-901-9018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DURAMER(R) ADVANTIM(R) POST STAB LSI TIBIAL INSERTKNEE COMPONENTWRIGHT MEDICAL TECHNOLOGY, INC.KRPNA1890-3210097A069777YNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-09-0401. R

Event Narratives#

D

Patient 1

ORIGINAL DATE OF SURGERY IN 1998. ALLEGEDLY BASE PLATE (LEFT KNEE) CRACKED ON MEDIAL SIDE FROM ANTERIOR TO POSTERIOR. 3 WEEKS AGO, PT HAD TERRIBLE PAIN. PT DID GREAT BEFORE THAT. ALLEGEDLY X-RAYS SHOWS LINE IN BACK PART OF LOCKING DETAIL.