FDA Adverse Event
Injury
Summary report: N
JOURNEY I BCS
MDR report key: 3834583
·
Received May 28, 2014
Report
- Report Number
- 1020279-2014-00331
- Event Type
- Injury
- Date Received
- May 28, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 15, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT A REVISION WAS PERFORMED DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313900 | JOURNEY I BCS | JOURN ART INS BCS STD 3-4 RT 9 | JWH | SMITH & NEPHEW, INC. | 12FM17881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |