IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM AR-504-PSC9

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-18 for IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM AR-504-PSC9 manufactured by Arthrex, Inc..

MAUDE Entry Details

Report Number1220246-2019-01365
MDR Report Key9207325
Date Received2019-10-18
Date of Report2019-10-18
Date of Event2019-09-19
Date Mfgr Received2019-09-27
Device Manufacturer Date2014-12-11
Date Added to Maude2019-10-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactVIK BAJNATH
Manufacturer Phone8009337001
Manufacturer G1ARTHREX, INC.
Manufacturer Street1370 CREEKSIDE BOULEVARD
Manufacturer CityNAPLES FL 341081945
Manufacturer CountryUS
Manufacturer Postal Code341081945
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
Generic NamePROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Product CodeKRR
Date Received2019-10-18
Model NumberIBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
Catalog NumberAR-504-PSC9
Lot Number113601430
Device Expiration Date2019-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-18

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