FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK SHORT
MDR report key: 2963852
·
Received February 15, 2013
Report
- Report Number
- 1043534-2013-00309
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 18, 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
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. PHOTOGRAPHIC IMAGES WERE MADE OF THE RETURNED PRODUCT.(B)(4).
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO NECK FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67048 | PROFEMUR(R) MODULAR FEMORAL NECK SHORT | HIP COMPONENT, CODE:LWJ | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | 0701171808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |