FDA Adverse Event
Injury
Summary report: N
SL PLUS MIA STEM
MDR report key: 2770048
·
Received October 3, 2012
Report
- Report Number
- 9613369-2012-00084
- Event Type
- Injury
- Date Received
- October 3, 2012
- Date of Event
- April 5, 2010
- Report Date
- September 5, 2012
- Manufacturer
- SMITH&NEPHEW -SWITZERLAND
- Product Code
- JDH
- 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 A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SL PLUS MIA STEM | FEMORAL COMPONENT | JDH | SMITH&NEPHEW -SWITZERLAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |