E1 44-36 STD HMRL BRNG EP-115393

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-03 for E1 44-36 STD HMRL BRNG EP-115393 manufactured by Zimmer Biomet, Inc..

MAUDE Entry Details

Report Number0001825034-2019-02203
MDR Report Key8662596
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-03
Date of Report2019-07-01
Date of Event2019-05-10
Date Mfgr Received2019-06-25
Device Manufacturer Date2019-03-06
Date Added to Maude2019-06-03
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 BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameE1 44-36 STD HMRL BRNG
Generic NamePROSTHESIS, EXTREMITY
Product CodePAO
Date Received2019-06-03
Catalog NumberEP-115393
Lot Number640960
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-03

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