FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 3241547
·
Received July 22, 2013
Report
- Report Number
- 1043534-2013-01183
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 17, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K003016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE 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 1043534-2013-01184, 01185 01186, 01187.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. (B)(4).
Description of Event or Problem · 1
ALLEGEDLY NECK BROKE OFF IN THE STEM. MEDIUM ACTIVITY LEVEL. SULFUR ALLERGIES. BMI: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339991 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT, CODE:LWJ | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | U0163249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |