FDA Adverse Event
Injury
Summary report: N
JOURNEY I BCS
MDR report key: 3040232
·
Received April 8, 2013
Report
- Report Number
- 1020279-2013-00197
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- March 14, 2013
- Report Date
- March 14, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO ARTICULAR INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144191 | JOURNEY I BCS | JOURN ART INS BCS STD 7-8 RT11 | JWH | SMITH & NEPHEW, INC. | 07CM10615 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |