FDA Adverse Event
Injury
Summary report: N
JOURNEY BCS
MDR report key: 1012580
·
Received March 12, 2008
Report
- Report Number
- 1020279-2008-00086
- Event Type
- Injury
- Date Received
- March 12, 2008
- Report Date
- March 12, 2008
- Manufacturer
- SMITH & NEPHEW, INC./ORTHOPAEDIC DIV.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF THE INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOURNEY BCS | INSERT | HSH | SMITH & NEPHEW, INC./ORTHOPAEDIC DIV. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |