FDA Adverse Event
Injury
Summary report: N
KNEE IMPLANT
MDR report key: 4241366
·
Received November 10, 2014
Report
- Report Number
- 1020279-2014-00685
- Event Type
- Injury
- Date Received
- November 10, 2014
- Date of Event
- October 24, 2014
- Report Date
- October 24, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723282 | KNEE IMPLANT | JWH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |