FDA Adverse Event
Injury
Summary report: N
1020279-2011-00102
MDR report key: 2032408
·
Received March 29, 2011
Report
- Report Number
- 1020279-2011-00102
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- September 13, 2010
- Report Date
- March 29, 2011
- Manufacturer
- SMITH & NEPHEW, INC
- Product Code
- JWH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATELLA LOOSENED REQUIRING A REVISION SURGERY TO CORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JWH | SMITH & NEPHEW, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |