IDUO G2 UNK

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 2015-03-12 for IDUO G2 UNK manufactured by Conformis, Inc..

Event Text Entries

[5767134] It was reported that revision surgery occurred for patient with a bicompartmental knee implant. Reason for revision is unknown.
Patient Sequence No: 1, Text Type: D, B5


[13031898] It was reported that revision surgery occurred for patient with a bicompartmental knee implant. Reason for revision is unknown. Device identifying information was not provided. Review of the device history record was not possible as the serial number of the device was not reported.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004153240-2015-00039
MDR Report Key4606371
Report Source05
Date Received2015-03-12
Date of Report2015-02-02
Date Mfgr Received2015-02-02
Date Added to Maude2015-03-17
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 01703
Manufacturer CountryUS
Manufacturer Postal01703
Manufacturer Phone7813459195
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDUO G2
Generic NameBICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
Product CodeOOG
Date Received2015-03-12
Catalog NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONFORMIS, INC.
Manufacturer Address28 CROSBY DRIVE BEDFORD MA 01730 US 01730


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-03-12

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