FDA Adverse Event
Injury
Summary report: N
PROFEMUR MODULAR FEMORAL NECK
MDR report key: 1251271
·
Received December 4, 2008
Report
- Report Number
- 1043534-2008-00343
- Event Type
- Injury
- Date Received
- December 4, 2008
- Date of Event
- November 24, 2008
- Report Date
- November 24, 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
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00344, 00345.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO FRACTURED MODULAR NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR MODULAR FEMORAL NECK | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | U0370580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |