FDA Adverse Event
Injury
Summary report: N
ECHELON STEM
MDR report key: 3143166
·
Received June 3, 2013
Report
- Report Number
- 1020279-2013-00299
- Event Type
- Injury
- Date Received
- June 3, 2013
- Date of Event
- May 27, 2013
- Report Date
- May 27, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CHRONIC DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244648 | ECHELON STEM | HIP IMPLANT | JDH | SMITH & NEPHEW, INC. | 13BM02342A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |