FDA Adverse Event
Injury
Summary report: N
HIP IMPLANT
MDR report key: 3943518
·
Received July 18, 2014
Report
- Report Number
- 1020279-2014-00433
- Event Type
- Injury
- Date Received
- July 18, 2014
- Date of Event
- April 9, 2009
- Report Date
- February 19, 2015
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURED IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422709 | HIP IMPLANT | JDH | SMITH & NEPHEW, INC. | 07DAB0023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4)| (B)(4) |