SMARTSET MV 40G - EO 3122-040 3122040

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 SMARTSET MV 40G - EO 3122-040 3122040 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[185897013] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter occupation: legal.
Patient Sequence No: 1, Text Type: N, H10


[185897014] After review of medical record dated (b)(6) 2020, it was reported that patient suffered from adhesion, pain, allergic reaction. Doi: (b)(6) 2018, dor: (b)(6) 2019, right knee.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09813
MDR Report Key9908044
Report SourceCONSUMER,OTHER
Date Received2020-03-31
Date of Report2019-02-06
Date of Event2019-02-06
Date Mfgr Received2020-03-17
Device Manufacturer Date2018-06-29
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 ContactMS. KARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY CMW - 9610921
Manufacturer StreetCORNFORD RD
Manufacturer CityBLACKPOOL FY4 4QQ
Manufacturer CountryUK
Manufacturer Postal CodeFY4 4QQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMARTSET MV 40G - EO
Generic NameBONE CEMENT : BONE CEMENT
Product CodeLOD
Date Received2020-03-31
Model Number3122-040
Catalog Number3122040
Lot Number8751053
Device Expiration Date2020-02-29
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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