FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 1780006
·
Received August 2, 2010
Report
- Report Number
- 1043534-2010-00325
- Event Type
- Injury
- Date Received
- August 2, 2010
- Date of Event
- June 22, 2010
- Report Date
- May 2, 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
- RS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 1043534-2010-00326, 00327. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO BROKEN COMPONENT.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO 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. | W05321214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |