D
Patient 1
REVISION SURGERY -- FRACTURED POST. ALLEGEDLY KNEE WAS NOT STABLE AND REQUIRED REVISION SURGERY.
MAUDE MDR 201455
- MDR report key
- 201455
- Report number
- 1043534-1998-00111
- Event key
- 0
- Event type
- 3
- Date of event
- 1998-11-02
- Date received
- 1998-12-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADVANTIM POSTERIOR STABILIZED FEMORAL STEM | KNEE COMPONENT | WRIGHT MEDICAL TECHNOLOGY, INC. | KRP | NA | 1890-0038 | M659160 | Y | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1998-12-09 | 0 | 1. R |