FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) TL STEM
MDR report key: 3211710
·
Received July 8, 2013
Report
- Report Number
- 1043534-2013-01121
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- August 13, 2012
- Report Date
- February 20, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043435-2013-01118, 01119, 01120.
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Description of Event or Problem · 1
ALLEGEDLY PT. HAD PERSISTENT WORSENING PAIN IN THE RIGHT HIP. SHE HAD NOTICEABLE LIMB LENGTH DISCREPANCY. SHE WAS FOUND TO HAVE ELEVATED METAL ION LEVELS AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311796 | PROFEMUR(R) TL STEM | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 029783869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |