FDA Adverse Event
Injury
Summary report: N
PLUS
MDR report key: 1893188
·
Received November 8, 2010
Report
- Report Number
- 9613369-2010-00063
- Event Type
- Injury
- Date Received
- November 8, 2010
- Date of Event
- July 28, 2010
- Report Date
- November 8, 2010
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO A FRACTURE OF THE GLENOID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUS | PROMOS REVERSE | HSD | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |