DELTA CER HEAD 12/14 36MM +8.5 1365-36-330 136536330

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for DELTA CER HEAD 12/14 36MM +8.5 1365-36-330 136536330 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[186559865] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186559866] It was reported that patient had left hip pain which was manage with bursal and topical injection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09375
MDR Report Key9884705
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-13
Date of Event2017-09-01
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY IRELAND - 9616671
Manufacturer StreetLOUGHBEG RINGASKIDDY
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDELTA CER HEAD 12/14 36MM +8.5
Generic NameARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Product CodeLZO
Date Received2020-03-26
Model Number1365-36-330
Catalog Number136536330
Lot Number8309063
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-26

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