FDA Adverse Event
Summary report: N
GII
MDR report key: 1903876
·
Received November 20, 2010
Report
- Report Number
- 1020279-2010-00326
- Date Received
- November 20, 2010
- Date of Event
- October 7, 2010
- Report Date
- January 7, 2010
- Manufacturer
- SMITH-NEPHEW INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GII | TIBIA INSERT | JWH | SMITH-NEPHEW INC. | 09DM13840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | (B)(4)| (B)(4) |