PROFMEUR? GLADIATOR HA STEM PRGLHA12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for PROFMEUR? GLADIATOR HA STEM PRGLHA12 manufactured by Microport Orthopedics Inc..

Event Text Entries

[186176088] This event will be updated once the investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10


[186176089] Allegedly, periprosthetic fracture by fall with stem loosening. Components removed during revision: femoral component and modular neck
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010536692-2020-00299
MDR Report Key9904255
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-19
Date Facility Aware2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-31
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 Street5677 AIRLINE ROAD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal38002
Manufacturer Phone9018674771
Manufacturer G1MICROPORT ORTHOPEDICS INC.
Manufacturer Street5677 AIRLINE RD.
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROFMEUR? GLADIATOR HA STEM
Generic NameHIP COMPONENT
Product CodeHWT
Date Received2020-03-31
Model NumberPRGLHA12
Catalog NumberPRGLHA12
Lot Number039770171
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICROPORT ORTHOPEDICS INC.
Manufacturer Address5677 AIRLINE RD. ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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