FDA.reportPublic FDA data

MAUDE MDR 9306268

MDR report key
9306268
Report number
0001822565-2019-04801
Event key
0
Event type
3
Date of event
2019-02-22
Date received
2019-11-11
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
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZIMMER UNICOMPARTMENTAL PRECOAT TIBIAL COMPONENT SIZE 4PROSTHESIS, KNEEZIMMER BIOMET, INC.HSXN/A0058420040261927336R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-1101. H; 2. R

Event Narratives#

No narrative records found.