GLENOSPHERE 36 MM DIAMETER NI 00434903611

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-19 for GLENOSPHERE 36 MM DIAMETER NI 00434903611 manufactured by Zimmer Biomet, Inc..

MAUDE Entry Details

Report Number0001822565-2020-00606
MDR Report Key9727865
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-02-19
Date of Report2020-03-04
Date of Event2020-02-06
Date Mfgr Received2020-02-12
Device Manufacturer Date2018-03-05
Date Added to Maude2020-02-19
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
Event Type3
Type of Report3

Device Details

Brand NameGLENOSPHERE 36 MM DIAMETER
Generic NamePROSTHESIS, SHOULDER
Product CodeKWT
Date Received2020-02-19
Returned To Mfg2020-02-12
Model NumberNI
Catalog Number00434903611
Lot Number63960577
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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
101. Hospitalization; 2. Required No Informationntervention 2020-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.