FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 2061066
·
Received April 18, 2011
Report
- Report Number
- 1043534-2011-00159
- Event Type
- Injury
- Date Received
- April 18, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 17, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K003016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.VISUALLY EXAMINED. COMPLAINT REVIEWED. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED.(B)(4)
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00160.
Description of Event or Problem · 1
ALLEGEDLY THE COMPONENT BROKE AND REQUIRED REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | 016296909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R |