FDA Adverse Event
Injury
Summary report: N
PROFEMUR MODULAR FEMORAL NECK
MDR report key: 1210563
·
Received October 22, 2008
Report
- Report Number
- 1043534-2008-00312
- Event Type
- Injury
- Date Received
- October 22, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 23, 2008
- 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, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS IS THE SAME EVENT AS 1043534-2008-00313, 00314. THIS REPORT WILL BE UPDATED, WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY VERY ACTIVE RACE CAR DRIVER. ALLEGEDLY REVISED NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR MODULAR FEMORAL NECK | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 075235974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R |