ARROW 265129 - CoCr OFF-CENTRED HUMERAL HEAD, ?48 H16 265129

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 2020-02-26 for ARROW 265129 - CoCr OFF-CENTRED HUMERAL HEAD, ?48 H16 265129 manufactured by Fh Industrie.

MAUDE Entry Details

Report Number3003898228-2020-00002
MDR Report Key9755018
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-02-26
Date of Report2020-02-29
Date of Event2019-10-23
Date Mfgr Received2020-01-29
Device Manufacturer Date2013-04-01
Date Added to Maude2020-02-26
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 ContactMS. C HERNOUX
Manufacturer Street3 RUE DE LA FOR
Manufacturer CityHEIMSBRUNN, 68990
Manufacturer CountryFR
Manufacturer Postal68990
Manufacturer G1FH INDUSTRIE
Manufacturer Street6 RUE NOBEL
Manufacturer CityQUIMPER, 29000
Manufacturer CountryFR
Manufacturer Postal Code29000
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW
Generic NameARROW GLENOID INSERT 46
Product CodeKWT
Date Received2020-02-26
Returned To Mfg2020-01-29
Model Number265129 - CoCr OFF-CENTRED HUMERAL HEAD, ?48 H16
Catalog Number265129
Lot NumberG00079
Device Expiration Date2019-10-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerFH INDUSTRIE
Manufacturer Address6 RUE NOBEL QUIMPER, 29000 FR 29000


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-26

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