D
Patient 1
IT WAS REPORTED THAT MRI DEMONSTRATED MILD DIFFUSE FATTY INFILTRATION. RIGHT HIP ASPIRATION WAS PERFORMED.
MAUDE MDR 9409351
- MDR report key
- 9409351
- Report number
- 1020279-2019-04274
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-02-24
- Date received
- 2019-12-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DR. SARAH FREESTONE
- Address
- 1450 BROOKS ROAD MEMPHIS TN 38116 US
- Phone
- 44-44-0447
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | R3 0 HOLE ACET SHELL 52MM | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS | SMITH & NEPHEW, INC. | MBL | 71331852 | 71331852 | 11LM10890 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-12-04 | 0 | 1. R |