FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1850560
·
Received October 1, 2010
Report
- Report Number
- 1020279-2010-00279
- Event Type
- Injury
- Date Received
- October 1, 2010
- Date of Event
- July 13, 2010
- Report Date
- October 1, 2010
- Manufacturer
- SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED, DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | FEMORAL COMPONENT | JWH | SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |