FDA.reportPublic FDA data

MAUDE MDR 9829254

MDR report key
9829254
Report number
0001825034-2020-01072
Event key
0
Event type
3
Date of event
2020-02-05
Date received
2020-03-13
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
1G7 NEUTRAL E1 LINER 36MM EPROSTHESIS, HIPZIMMER BIOMET, INC.PBIN/A0100008576592218R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1301. H; 2. R

Event Narratives#

No narrative records found.