FDA Adverse Event
Injury
Summary report: N
GENESIS II
MDR report key: 1202743
·
Received October 17, 2008
Report
- Report Number
- 1020279-2008-00277
- Event Type
- Injury
- Date Received
- October 17, 2008
- Report Date
- October 17, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED, DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS II | INSERT | HSH | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | NA | 00302172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R | LOT NUMBER: UNK| LOT NUMBER: UNK| LOT NUMBER: UNK |