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 |