FITMORE HIP STEM, TRIAL RASP, B/9 N/A 01.00559.209

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-04 for FITMORE HIP STEM, TRIAL RASP, B/9 N/A 01.00559.209 manufactured by Zimmer Gmbh.

MAUDE Entry Details

Report Number0009613350-2019-00428
MDR Report Key8761943
Date Received2019-07-04
Date of Report2019-08-05
Date of Event2019-06-25
Date Mfgr Received2019-07-08
Device Manufacturer Date2015-10-19
Date Added to Maude2019-07-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER GMBH
Manufacturer StreetSULZER ALLEE 8 SULZER INDUSTRIE PARK
Manufacturer CityWINTERTHUR 8404
Manufacturer CountrySZ
Manufacturer Postal Code8404
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameFITMORE HIP STEM, TRIAL RASP, B/9
Generic NameN/A
Product CodeHTR
Date Received2019-07-04
Model NumberN/A
Catalog Number01.00559.209
Lot Number152826274
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER GMBH
Manufacturer AddressSULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-04

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