FDA Adverse Event
Malfunction
Summary report: N
PROFEMUR RADEL TRIAL NECK
MDR report key: 1081870
·
Received July 21, 2008
Report
- Report Number
- 1043534-2008-00165
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- April 4, 2008
- Report Date
- April 4, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LXH
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS A PRODUCT MALFUNCTION. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY BROKEN TRIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR RADEL TRIAL NECK | LXH | WRIGHT MEDICAL TECHNOLOGY, INC. | 91992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |