D
Patient 1
ASEPTIC LOOSENING WITHIN SIX MONTHS AFTER INSTALLATION SURGERY. NO INDICATION OF AN INFECTION. PROSTHESIS WAS MANUFACTURED BY SMITH AND NEPHEW AND THE MODEL NAME IS PROFIX.
MAUDE MDR 3973004
- MDR report key
- 3973004
- Report number
- MW5037532
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-10-28
- Date received
- 2014-07-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PROFIX | PROFIX | SMITH AND NEPHEW | HSA |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-07-29 | 0 | 1. H; 2. R; 3. S |