FDA Adverse Event
Injury
Summary report: N
GENESIS II
MDR report key: 2014305
·
Received March 10, 2011
Report
- Report Number
- 1020279-2010-00158
- Event Type
- Injury
- Date Received
- March 10, 2011
- Report Date
- June 11, 2010
- Manufacturer
- SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS II | INSERT | JWH | SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |