FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) RAZ STEM
MDR report key: 3661133
·
Received March 5, 2014
Report
- Report Number
- 3010536692-2014-00432
- Event Type
- Injury
- Date Received
- March 5, 2014
- Date of Event
- January 9, 2013
- Report Date
- February 18, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. EVENT CODE IS ADDRESSED IN PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00429, -00430, -00431. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133830 | PROFEMUR(R) RAZ STEM | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | 036284376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |