FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 3241495
·
Received July 22, 2013
Report
- Report Number
- 1043534-2013-01191
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- June 8, 2013
- Report Date
- July 17, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME INCIDENT AS 1043534-2013-01192. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ALLEGEDLY BREAKAGE OF IMPLANTED WHEN MOWING THE LAWN. ORIG. SURG. 2004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340192 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT, CODE:LWJ | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | T12134935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |