IDUO G2 M5723INT0600220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-26 for IDUO G2 M5723INT0600220 manufactured by Conformis, Inc..

Event Text Entries

[181097888] It was reported that the patient has an infection. Revision surgery is planned to exchange the poly insert. Review of the device history record indicates that the device was manufactured to specification. All sterilization requirements were met.
Patient Sequence No: 1, Text Type: N, H10


[181097889] It was reported that the patient has an infection. Revision surgery is planned to exchange the poly insert.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004153240-2020-00048
MDR Report Key9759372
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-26
Date of Report2020-02-26
Date of Event2020-02-01
Date Mfgr Received2020-02-05
Device Manufacturer Date2018-06-05
Date Added to Maude2020-02-26
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 ContactEMMANUEL NYAKAKO
Manufacturer Street600 TECHNOLOGY PARK DRIVE
Manufacturer CityBILLERICA, MA
Manufacturer CountryUS
Manufacturer Phone3459164
Manufacturer G1CONFORMIS, INC.
Manufacturer Street600 RESEARCH DRIVE
Manufacturer CityWILMINGTON, MA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDUO G2
Generic NameBICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
Product CodeNPJ
Date Received2020-02-26
Catalog NumberM5723INT0600220
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONFORMIS, INC.
Manufacturer Address600 TECHNOLOGY PARK DRIVE BILLERICA, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-26

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