FDA Adverse Event
Death
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 4033244
·
Received August 25, 2014
Report
- Report Number
- 3010536692-2014-01222
- Event Type
- Death
- Date Received
- August 25, 2014
- Date of Event
- August 3, 2012
- Report Date
- August 6, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO BROKEN MODULAR NECK (RIGHT) AND ALLEGEDLY SUFFERED A HEART ATTACK DUE TO THE STRESS ON HIS BODY CAUSED BY THE EMERGENCY REVISION SURGERY. THE PATIENT DIED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510916 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | U0570553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |