FDA Adverse Event
Injury
Summary report: N
REFLECTION PRIMARY LINER
MDR report key: 2972292
·
Received February 21, 2013
Report
- Report Number
- 1020279-2013-00113
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 8, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75600 | REFLECTION PRIMARY LINER | HIP IMPLANT | JDH | SMITH & NEPHEW, INC. | 12GM07919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |