FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) SUPER FINISH FEMORAL
MDR report key: 2605405
·
Received June 8, 2012
Report
- Report Number
- 1043534-2012-00522
- Event Type
- Injury
- Date Received
- June 8, 2012
- Date of Event
- April 9, 2012
- Report Date
- May 7, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KXA
- PMA / PMN Number
- K944752
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-521.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND PHOTOGRAPHIC IMAGES WERE MADE. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO HIGH METAL ION LEVELS WITH CLUNKING AND SQUEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERVE(R) SUPER FINISH FEMORAL | HIP COMPONENT, CODE:KXA | KXA | WRIGHT MEDICAL TECHNOLOGY, INC. | 086366885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |