SIGMA PS CEM FEM SZ4 R 1960-50-400 196050400

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 2020-03-31 for SIGMA PS CEM FEM SZ4 R 1960-50-400 196050400 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[186808939] (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


[186808940] The patient was revised to address infection of the knee. All implants explanted. No surgical delay. No further information is available. Doi: (b)(6) 2019. Dor: (b)(6) 2020, right knee.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09764
MDR Report Key9905472
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-13
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-02-12
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 ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1CORK MFG & MATERIAL WAREHOUSE
Manufacturer StreetLOUGHBEG RINGASKIDDY
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIGMA PS CEM FEM SZ4 R
Generic NameSIGMA KNEE PRIMARY : KNEE FEMORAL
Product CodeJWH
Date Received2020-03-31
Model Number1960-50-400
Catalog Number196050400
Lot Number9045509
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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