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.
[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
Report Number | MW5011301 |
MDR Report Key | 1399140 |
Date Received | 2009-06-03 |
Date of Report | 2009-06-03 |
Date of Event | 2009-04-20 |
Date Added to Maude | 2009-06-11 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | KMI |
Generic Name | WRIST PROSTHESIS |
Product Code | KWM |
Date Received | 2009-06-03 |
Returned To Mfg | 2009-06-03 |
Lot Number | 7855-40-7899 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | KMI |
Manufacturer Address | CARLSBAD CA US |
Brand Name | KMI |
Generic Name | WRIST PROSTHESIS |
Product Code | KWM |
Date Received | 2009-06-03 |
Returned To Mfg | 2009-06-03 |
Lot Number | 7762D-34R-8153 |
Device Availability | R |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | KMI |
Manufacturer Address | CARLSBAD CA US |
Brand Name | KMI |
Generic Name | WRIST PROSTHESIS |
Product Code | KWM |
Date Received | 2009-06-03 |
Returned To Mfg | 2009-06-03 |
Lot Number | 7763-14-7830 |
Device Availability | R |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | KMI |
Manufacturer Address | CARLSBAD CA US |
Brand Name | SCREWS |
Generic Name | SCREWS |
Product Code | HWC |
Date Received | 2009-06-03 |
Returned To Mfg | 2009-06-03 |
Catalog Number | 26-4535-1 |
Device Availability | R |
Device Sequence No | 4 |
Device Event Key | 0 |
Manufacturer | KMI |
Manufacturer Address | CARLSBAD DC US |
Brand Name | SCREWS |
Generic Name | SCREWS |
Product Code | HWC |
Date Received | 2009-06-03 |
Returned To Mfg | 2009-06-03 |
Catalog Number | 26-4520-1 |
Device Availability | R |
Device Sequence No | 5 |
Device Event Key | 0 |
Manufacturer | KMI |
Manufacturer Address | CARLSBAD CA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Deathisabilit | 2009-06-03 |