D
Patient 1
IT WAS REPORTED THAT THE PATIENT HAS A POLARSTEM DEVICE IN PLACE SINCE 2017 AND WAS EXPERIENCING ELEVATED COBALT LEVELS. REVISION SURGERY WAS PERFORMED AND THE POLY WAS EXPLANTED AND AN OXINIU HEAD WAS USED.
MAUDE MDR 9513573
- MDR report key
- 9513573
- Report number
- 1020279-2019-04570
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-25
- Date received
- 2019-12-23
- 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 36MM X MM56 | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL POROUS | SMITH & NEPHEW, INC. | MBL | 71332756 | 71332756 | 14MM12431 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-12-23 | 0 | 1. R |