UNKNOWN SHOULDER HUMERAL STEMS UNK SHOULDER HUMERAL STEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-08 for UNKNOWN SHOULDER HUMERAL STEMS UNK SHOULDER HUMERAL STEM manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

Report Number1818910-2019-115432
MDR Report Key9301647
Date Received2019-11-08
Date of Report2019-10-30
Date of Event2013-06-08
Date Mfgr Received2019-11-12
Date Added to Maude2019-11-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1JTE WARSAW MFG SITE
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN SHOULDER HUMERAL STEMS
Generic NameSHOULDER HUMERAL STEMS
Product CodeHXA
Date Received2019-11-08
Catalog NumberUNK SHOULDER HUMERAL STEM
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-08

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