FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) RAZ STEM
MDR report key: 3051321
·
Received April 10, 2013
Report
- Report Number
- 1043534-2013-00639
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- April 26, 2011
- Report Date
- March 1, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 1043534-2013-00636, 00637, 00638.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO METAL ON METAL COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149066 | PROFEMUR(R) RAZ STEM | HIP COMPONENT, CODE:LPH | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 057413447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |