FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 1971221
·
Received January 26, 2011
Report
- Report Number
- 1043534-2011-00023
- Event Type
- Injury
- Date Received
- January 26, 2011
- Date of Event
- December 16, 2010
- Report Date
- March 4, 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
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUTED. THIS EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00024, 00025, 00026.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY. (B)(6)
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 | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | 035486783 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| R |