ITOTAL G2 M57250600020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-22 for ITOTAL G2 M57250600020 manufactured by Conformis.

Event Text Entries

[18874519] Tibial loosening was reported. Revision surgery is planned.
Patient Sequence No: 1, Text Type: D, B5


[19169066] Review of the device history record indicates that the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004153240-2015-00139
MDR Report Key4943369
Report Source05
Date Received2015-07-22
Date of Report2015-06-30
Date of Event2015-06-01
Date Mfgr Received2015-06-30
Device Manufacturer Date2015-05-01
Date Added to Maude2015-07-28
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 ContactKARINA SNOW
Manufacturer Street28 CROSBY DRIVE
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal01730
Manufacturer Phone7813459195
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameITOTAL G2
Generic NameTOTAL KNEE REPLACEMENT SYSTEM
Product CodeOOG
Date Received2015-07-22
Catalog NumberM57250600020
Device Expiration Date2015-10-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONFORMIS
Manufacturer Address28 CROSBY DRIVE BEDFORD MA 01730 US 01730


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-07-22

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