FDA Adverse Event
Injury
Summary report: N
EMPERION
MDR report key: 2110648
·
Received June 1, 2011
Report
- Report Number
- 1020279-2011-00184
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- June 23, 2010
- Report Date
- June 1, 2011
- Manufacturer
- SMITH AND NEPHEW, INC
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EMPERION | HIP STEM | LZO | SMITH AND NEPHEW, INC | 06HM02019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization |