SIG RP AOX STB INS SZ3 12.5 1961-92-132 196192132

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 SIG RP AOX STB INS SZ3 12.5 1961-92-132 196192132 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[185895940] Product complaint # (b)(4). Initial reporter occupation: lawyer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185895941] 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 Number1818910-2020-09814
MDR Report Key9908051
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2019-02-06
Date of Event2019-02-06
Date Mfgr Received2020-03-17
Device Manufacturer Date2016-03-16
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
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIG RP AOX STB INS SZ3 12.5
Generic NameSIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Product CodeNJL
Date Received2020-03-31
Model Number1961-92-132
Catalog Number196192132
Lot Number8263556
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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