MAUDE MDR 1098943

MDR report key
1098943
Report number
1035617-2008-00002
Event key
0
Event type
3
Date received
2008-05-15
Adverse event
0
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
DEBARA REESE
Address
200 W OHIO AVE DOVER OH 44622 US
Phone
330-330-3303
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZIMMER ORTHOPAEDIC SURGICAL PRODUCTSILZNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-05-150

Event Narratives#

N

Patient 1

HOSP WAS CONTACTED BY ZIMMER OSP ON TWO OCCASIONS TO TRY AND OBTAIN DEVICE FOR EVAL. THE RISK MGR HAS STATED THAT THE DEVICE IS BEING RETAINED AT THE HOSP. HOWEVER, SHE WILL TRY TO FOLLOW-UP WITH PHOTOS.