PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20 FGT-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-19 for PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20 FGT-20 manufactured by Tornier Inc..

Event Text Entries

[4921523] Possible allergy to the implant has appointment with the allergist on thursday (b)(6) 2014. Needs a sample or portion of the silicon and titanium of product that is in the fgt implant. Post op symptom: she came out of the surgery in pain (morphine was administered in the recovery room). Then pain and swelling in her foot. Swelling has reached all joints. Within 4 months of surgery, the downward progression started. Has had numerous tests done for ra, lupus, diabetes, etc. And they have all been negative.
Patient Sequence No: 1, Text Type: D, B5


[12207314] This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004983210-2014-00018
MDR Report Key4131197
Report Source04
Date Received2014-08-19
Date of Report2014-07-22
Date Mfgr Received2014-07-22
Date Added to Maude2014-10-01
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 FDA0
Event Location0
Manufacturer ContactKEVIN SMITH
Manufacturer Street10801 NESBITT AVE SOUTH
Manufacturer CityBLOOMINGTON MN 55437
Manufacturer CountryUS
Manufacturer Postal55437
Manufacturer Phone9524267643
Manufacturer G1TORNIER INC.
Manufacturer Street10801 NESBITT AVE SOUTH
Manufacturer CityBLOOMINGTON MN 55437
Manufacturer CountryUS
Manufacturer Postal Code55437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20
Generic NameNONE
Product CodeKWH
Date Received2014-08-19
Catalog NumberFGT-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORNIER INC.
Manufacturer AddressBLOOMINGTON MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-19

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