FDA Adverse Event
Death
Summary report: N
PROFEMUR MODULAR FEMORAL NECK
MDR report key: 1486499
·
Received September 25, 2009
Report
- Report Number
- 1043534-2009-00321
- Event Type
- Death
- Date Received
- September 25, 2009
- Date of Event
- September 18, 2009
- Report Date
- September 21, 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
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ATTEMPTS ARE BEING MADE TO HAVE THE PRODUCT RETURNED FOR EVALUATION. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2009-00322, 00323. THIS EVENT OCCURRED IN FOREIGN COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY, WHILE PLAYING GOLF, COMPONENT BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR MODULAR FEMORAL NECK | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 106379326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R |