FDA Adverse Event
Injury
Summary report: N
FEMORAL COMPONENT
MDR report key: 3933048
·
Received July 14, 2014
Report
- Report Number
- 1020279-2014-00423
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 19, 2014
- Report Date
- February 9, 2015
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410323 | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |