DLT TS CER HD 12/14 40MM +5.0 1365-40-720 136540720

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-31 for DLT TS CER HD 12/14 40MM +5.0 1365-40-720 136540720 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[186812004] (b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[186812005] Pcf and medical records received. After review of medical records patient was revised to addressed left infected total hip arthroplasty operative notes indicated scarring and small posterior superior defect. Pathology reprot reported of patchy acute and chronic inflammation. Doi: (b)(6) 2010 (cup, stem); doi: (b)(6) 2016 (liner & head); dor: (b)(6) 2017 left hip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09726
MDR Report Key9903554
Report SourceCONSUMER,OTHER
Date Received2020-03-31
Date of Report2020-03-13
Date of Event2017-02-14
Date Mfgr Received2020-03-13
Device Manufacturer Date2016-08-25
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
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 G1DEPUY IRELAND 9616671
Manufacturer StreetLOUGHBEG, RINGASKIDDY CO.
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDLT TS CER HD 12/14 40MM +5.0
Generic NameARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Product CodeLZO
Date Received2020-03-31
Model Number1365-40-720
Catalog Number136540720
Lot Number8374043
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 2020-03-31

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