D
Patient 1
ALLEGEDLY, IMPLANT WAS REVISED.
MAUDE MDR 440399
- MDR report key
- 440399
- Report number
- 1043534-2003-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2002-04-29
- Date received
- 2003-01-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DEBBY DAUER
- Address
- 5677 AIRLINE ROAD ARLINGTON TN 38002 US
- Phone
- 901-901-9018
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DURAMER ADVANTIM UNCONSTRAINED TIBIAL INSERT | KNEE COMPONENT | WRIGHT MEDICAL TECHNOLOGY, INC. | KRP | NA | 1880-0314 | 035A015419 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-01-16 | 0 | 1. R |