FDA Adverse Event
Injury
Summary report: N
PROFEMUR MODULAR FEMORAL NECK
MDR report key: 1456852
·
Received August 27, 2009
Report
- Report Number
- 1043534-2009-00267
- Event Type
- Injury
- Date Received
- August 27, 2009
- Date of Event
- August 4, 2009
- Report Date
- August 4, 2009
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K003016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
AGE OF DEVICE: LESS THAN ONE YEAR. INVESTIGATION IS NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THE USER FACILITY HAS ADVISED THEY WILL NOT SUBMIT A MEDWATCH 3500A. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2009-000268 AND 000269.
Description of Event or Problem · 1
ALLEGEDLY, THE PATIENT WAS GARDENING WHEN HE HEARD THE NECK FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR MODULAR FEMORAL NECK | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 047416742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R |