FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) Z STEM PLASMA SPRAYED
MDR report key: 4213899
·
Received October 30, 2014
Report
- Report Number
- 3010536692-2014-01545
- Event Type
- Injury
- Date Received
- October 30, 2014
- Date of Event
- February 17, 2014
- Report Date
- October 29, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. THE SUPPLEMENT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THE TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-01388, 01543, AND 01544.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697578 | PROFEMUR(R) Z STEM PLASMA SPRAYED | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | 088629369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |