TRIAXIAL TOTAL ELBOW SYSTEM HUMERAL COMPONENT 87-2011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-07-29 for TRIAXIAL TOTAL ELBOW SYSTEM HUMERAL COMPONENT 87-2011 manufactured by Johnson And Johnson Professionals, Inc..

Event Text Entries

[67371] Prosthesis began to break up and revision surgery was necessary to correct the problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219655-1997-00109
MDR Report Key108535
Report Source00
Date Received1997-07-29
Date of Report1997-07-29
Date Mfgr Received1997-07-08
Device Manufacturer Date1992-06-01
Date Added to Maude1997-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameTRIAXIAL TOTAL ELBOW SYSTEM HUMERAL COMPONENT
Generic NamePROSTHETIC ELBOW
Product CodeKWJ
Date Received1997-07-29
Model NumberNA
Catalog Number87-2011
Lot Number113LL
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedU
Device Sequence No1
Device Event Key106672
ManufacturerJOHNSON AND JOHNSON PROFESSIONALS, INC.
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-07-29

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