D
Patient 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE. STEM AND FEMORAL HEAD WERE EXPLANTED AND REPLACED FOR ZIMMER BIOMET STEM.
MAUDE MDR 9902734
- MDR report key
- 9902734
- Report number
- 1020279-2020-01090
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-04
- Date received
- 2020-03-31
- 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 | SYN HA PF FEM COMP SZ 15 | PRSTHSISHIPSMICNSTRINDUNCMNTDMTALPLYMRNONPORUSCLICUMPHSPHT | SMITH & NEPHEW, INC. | MEH | 71306715 | 71306715 | UNKNOWN | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H; 2. R |