KMI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-03 for KMI manufactured by Kmi.

Event Text Entries

[1200121] Failed prosthetic total wrist replacement, right wrist. Dates of use: 2003 - 2009. Diagnosis or reason for use: rheumatoid arthritis - total wrist replacement. Model#: kmi 26 3400 rt, catalog #: 26-1400, other #: ref#26-3400-rt. Universal total wrist impant, universal2 total wrist implant screws: 4. 5mm cancellus.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5011301
MDR Report Key1399140
Date Received2009-06-03
Date of Report2009-06-03
Date of Event2009-04-20
Date Added to Maude2009-06-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameKMI
Generic NameWRIST PROSTHESIS
Product CodeKWM
Date Received2009-06-03
Returned To Mfg2009-06-03
Lot Number7855-40-7899
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerKMI
Manufacturer AddressCARLSBAD CA US

Device Sequence Number: 2

Brand NameKMI
Generic NameWRIST PROSTHESIS
Product CodeKWM
Date Received2009-06-03
Returned To Mfg2009-06-03
Lot Number7762D-34R-8153
Device AvailabilityR
Device Sequence No2
Device Event Key0
ManufacturerKMI
Manufacturer AddressCARLSBAD CA US

Device Sequence Number: 3

Brand NameKMI
Generic NameWRIST PROSTHESIS
Product CodeKWM
Date Received2009-06-03
Returned To Mfg2009-06-03
Lot Number7763-14-7830
Device AvailabilityR
Device Sequence No3
Device Event Key0
ManufacturerKMI
Manufacturer AddressCARLSBAD CA US

Device Sequence Number: 4

Brand NameSCREWS
Generic NameSCREWS
Product CodeHWC
Date Received2009-06-03
Returned To Mfg2009-06-03
Catalog Number26-4535-1
Device AvailabilityR
Device Sequence No4
Device Event Key0
ManufacturerKMI
Manufacturer AddressCARLSBAD DC US

Device Sequence Number: 5

Brand NameSCREWS
Generic NameSCREWS
Product CodeHWC
Date Received2009-06-03
Returned To Mfg2009-06-03
Catalog Number26-4520-1
Device AvailabilityR
Device Sequence No5
Device Event Key0
ManufacturerKMI
Manufacturer AddressCARLSBAD CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2009-06-03

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