FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 1960439
·
Received January 13, 2011
Report
- Report Number
- 1043534-2011-00002
- Event Type
- Injury
- Date Received
- January 13, 2011
- Date of Event
- December 13, 2010
- Report Date
- December 17, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K021346
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00003, 00004. (B)(4)
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO A BROKEN COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 066354702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |