FDA Adverse Event
Injury
Summary report: N
1020279-2014-00289
MDR report key: 3782024
·
Received April 30, 2014
Report
- Report Number
- 1020279-2014-00289
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- April 21, 2014
- Report Date
- April 30, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR THE PATELLA DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260558 | JWH | SMITH & NEPHEW, INC. | 12JM14736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | 71420170/ 12KM02412| 71453221/ 12KM01623| 71421217/ 12KM15775| 71271440/ 12AC07310 |