FDA Adverse Event
Injury
Summary report: N
PROFEMUR MODULAR FEMORAL NECK
MDR report key: 1101754
·
Received August 7, 2008
Report
- Report Number
- 1043534-2008-00181
- Event Type
- Injury
- Date Received
- August 7, 2008
- Date of Event
- July 15, 2008
- Report Date
- July 14, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LWJ
- PMA / PMN Number
- K003016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE SURGEON AND THE USER FACILITY. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN REC'D FROM THE USE FACILITY. ATTEMPTS ARE BEING MADE TO HAVE THE PRODUCT RETURNED FOR EVAL. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
REVISION DUE TO ALLEGED BROKEN MODULAR NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR MODULAR FEMORAL NECK | LWJ | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | V02137467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| R |