D
Patient 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO CLOSED REDUCTIONS DUE TO RECURRENT DISLOCATIONS. THE FIRST CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2018 AND THE SECOND ONE ON (B)(6) 2018.
MAUDE MDR 9653097
- MDR report key
- 9653097
- Report number
- 1020279-2020-00427
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-07-03
- Date received
- 2020-01-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- 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 DEG XLPE ACET LNR 40MM X 64MM | PROSTH, HIP, SEMI-CONS, UNCEMENTED, METAL/POLYMER, POROUS | SMITH & NEPHEW, INC. | MBL | 71338683 | 71338683 | 10AM02372 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-31 | 0 | 1. H; 2. R |